Oscor Inc.

Address:3816 Desoto Blvd,PALM HARBOR,FL,34683,US

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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

pacemaker lead Adaptor (DTD) (6) INTRODUCER, CATHETER (DYB) (3) Permanent Pacemaker Electrode (DTB) (1)

Premarket Exempt

Clear

TourGuide™ Steerable Sheath - 00643169936256 Catalog Number : TG0859017

Device Description : Steerable Sheath, 8.5F

Device Class : 2

Duns Number: 101835833

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

Lead Adaptor - 00802526497506 Catalog Number : BIS/BLV-4402

Device Description : Lead Adaptor

Device Class : 2

Duns Number: 101835833

Premarket Exempt : No

Product Code : DTD

Prescription Use : Yes

Device Count : 1

Lead Adaptor - 00802526497513 Catalog Number : BLV/BIS-4403

Device Description : Lead Adaptor

Device Class : 2

Duns Number: 101835833

Premarket Exempt : No

Product Code : DTD

Prescription Use : Yes

Device Count : 1

Lead Adaptor - 00802526497520 Catalog Number : C/IS-10 SS2

Device Description : Lead Adaptor

Device Class : 2

Duns Number: 101835833

Premarket Exempt : No

Product Code : DTD

Prescription Use : Yes

Device Count : 1

Lead Adaptor - 00802526497537 Catalog Number : B/IS-15 SS2

Device Description : Lead Adaptor

Device Class : 2

Duns Number: 101835833

Premarket Exempt : No

Product Code : DTD

Prescription Use : Yes

Device Count : 1

VV-PLUG - 00802526497544 Catalog Number : VV-PLUG

Device Class : 3

Duns Number: 101835833

Premarket Exempt : No

Product Code : DTB

Prescription Use : No

Device Count : 1

LV-1 Plug - 00802526505300 Catalog Number : LV-1 PLUG

Device Class : 2

Duns Number: 101835833

Premarket Exempt : No

Product Code : DTD

Prescription Use : Yes

Device Count : 1

VV-Plug - 00802526540608 Catalog Number : VV-PLUG

Device Class : 2

Duns Number: 101835833

Premarket Exempt : No

Product Code : DTD

Prescription Use : Yes

Device Count : 1

Introducer Kit for Impella® - 00813502010237 Catalog Number : 0052-3014

Device Description : Hemostatic Peel Away Introducer System with Infusion Sideport, 14F

Device Class : 2

Duns Number: 101835833

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

Introducer Kit for Impella® - 00813502010244 Catalog Number : 0052-3015

Device Description : Hemostatic Peel Away Introducer System with Infusion Sideport, 14F

Device Class : 2

Duns Number: 101835833

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

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