IMPERATIVE CARE, INC.

Address:1359 Dell Ave,Campbell,CA,95008,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

Catheter, Percutaneous (DQY) (6) Catheter, Thrombus Retriever (NRY) (4)

Premarket Exempt

Clear

TRX™ Long Sheath - 00812212030009 Catalog Number : ICAC088080

Device Description : TRX™ 6F Long Sheath, 80 cm

Device Class : 2

Duns Number: 080816678

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

TRX™ Long Sheath - 00812212030016 Catalog Number : ICAC088090

Device Description : TRX™ 6F Long Sheath, 90 cm

Device Class : 2

Duns Number: 080816678

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

TracStar™ Large Distal Platform - 00812212030023 Catalog Number : ICAC088100

Device Description : TracStar™ 6F 088 LDP, 100 cm

Device Class : 2

Duns Number: 080816678

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

TracStar™ Large Distal Platform - 00812212030030 Catalog Number : ICAC088110

Device Description : TracStar™ 6F 088 LDP, 110 cm

Device Class : 2

Duns Number: 080816678

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

ZOOM™ Reperfusion Catheter - 00812212030061 Catalog Number : ICRC071137

Device Description : ZOOM 071 137 cm RC

Device Class : 2

Duns Number: 080816678

Premarket Exempt : No

Product Code : NRY

Prescription Use : Yes

Device Count : 1

ZOOM™ Reperfusion Catheter - 00812212030078 Catalog Number : ICRC055137

Device Description : ZOOM 055 137 cm RC

Device Class : 2

Duns Number: 080816678

Premarket Exempt : No

Product Code : NRY

Prescription Use : Yes

Device Count : 1

ZOOM™ Reperfusion Catheter - 00812212030085 Catalog Number : ICRC045144

Device Description : ZOOM 045 144 cm RC

Device Class : 2

Duns Number: 080816678

Premarket Exempt : No

Product Code : NRY

Prescription Use : Yes

Device Count : 1

ZOOM™ Reperfusion Catheter - 00812212030092 Catalog Number : ICRC035158

Device Description : ZOOM 035 158 cm RC

Device Class : 2

Duns Number: 080816678

Premarket Exempt : No

Product Code : NRY

Prescription Use : Yes

Device Count : 1

TracStar™ Large Distal Platform - 00812212030108 Catalog Number : ICAC088080

Device Description : TracStar™ 6F 088 LDP, 80 cm

Device Class : 2

Duns Number: 080816678

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

TracStar™ Large Distal Platform - 00812212030115 Catalog Number : ICAC088090

Device Description : TracStar™ 6F 088 LDP, 90 cm

Device Class : 2

Duns Number: 080816678

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

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