MARBLEHEAD MEDICAL LLC

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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) (4) Catheter, Percutaneous, Neurovasculature (QJP) (4)

Premarket Exempt

Clear

Marblehead Medical - 00860003254608 Catalog Number : 100240

Device Description : BOSS Balloon Guide Catheter

Device Class : 2

Duns Number: 080473303

Premarket Exempt : No

Product Code : QJP, DQY

Prescription Use : Yes

Device Count : 1

Marblehead Medical - 00860003254615 Catalog Number : 100240-D

Device Description : BOSS Balloon Guide Catheter, DEMO UNIT, Not for Human Use

Device Class : 2

Duns Number: 080473303

Premarket Exempt : No

Product Code : QJP, DQY

Prescription Use : Yes

Device Count : 1

Marblehead Medical - 08600032546006 Catalog Number : 100240

Device Description : BOSS Balloon Guide Catheter

Device Class : 2

Duns Number: 080473303

Premarket Exempt : No

Product Code : QJP, DQY

Prescription Use : Yes

Device Count : 1

Marblehead Medical - 08600032546013 Catalog Number : 100240-D

Device Description : BOSS Balloon Guide Catheter, DEMO UNIT, Not for Human Use

Device Class : 2

Duns Number: 080473303

Premarket Exempt : No

Product Code : QJP, DQY

Prescription Use : Yes

Device Count : 1

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