SENTREHEART, INC

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Suture, Nonabsorbable, Synthetic, Polyethylene (GAT) (3) Instrument, Ligature Passing And Knot Tying (HCF) (2) Catheter, Percutaneous (DQY) (1) Cutter, Surgical (FZT) (1) Instrument, Manual, Surgical, General Use (MDM) (1) Wire, Guide, Catheter (DQX) (1)

Premarket Exempt

No Yes

Clear

EndoCATH - M95520060 Catalog Number : 2006

Device Description : Large Occlusion Balloon Catheter

Device Class : 2

Duns Number: 068810802

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

Lariat - M95530050 Catalog Number : 3005

Device Description : Suture Delivery Device

Device Class : 1

Duns Number: 068810802

Premarket Exempt : No

Product Code : HCF, GAT

Prescription Use : Yes

Device Count : 1

Lariat - M95530060 Catalog Number :

Device Description : Suture Delivery Device

Device Class : 1

Duns Number: 068810802

Premarket Exempt : No

Product Code : HCF, GAT

Prescription Use : Yes

Device Count : 1

FindrWIRZ - M95540050 Catalog Number : 4005

Device Description : FindrWIRZ Guidewire System

Device Class : 2

Duns Number: 068810802

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

SureCUT - M95550010 Catalog Number : 5001

Device Description : A sterile, hand-held surgical instrument designed for cutting sutures using a me A sterile, hand-held surgical instrument designed for cutting sutures using a mechanical action. It typically has a protected scalpel-like blade or a scissors-like cutting end, and a proximal manual actuator. This is a single-use device.

Device Class : 1

Duns Number: 068810802

Premarket Exempt : Yes

Product Code : FZT

Prescription Use : Yes

Device Count : 1

SofTIP - M95560020 Catalog Number : 6002

Device Description : A sterile tube-like device intended to facilitate the use of an open-surgery lig A sterile tube-like device intended to facilitate the use of an open-surgery ligature loop ligator by guiding and protecting its passage through other tissues. It is made of plastic materials. This is a single-use device.

Device Class : 2

Duns Number: 068810802

Premarket Exempt : No

Product Code : GAT

Prescription Use : Yes

Device Count : 1

Tensure - M95580020 Catalog Number : 8002

Device Description : A sterile, manual, hand-held surgical device intended for controlled tightening A sterile, manual, hand-held surgical device intended for controlled tightening of a ligature loop in situ (e.g., during vascular surgery). The ligature is intended to be loaded into the device, which typically includes a sliding mechanism, allowing controlled manual tightening; the device may also include tightening markers. This is a single-use device

Device Class : 1

Duns Number: 068810802

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

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