Covidien LP

Address:161 CHESHIRE LANE,Plymouth,MN,55441,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

STENT, ILIAC (NIO) (6) Stents, drains and dilators for the biliary ducts (FGE) (6) Catheter, peripheral, atherectomy (MCW) (4)

Premarket Exempt

No Yes

Clear

Visi-Pro™ - 00643169788015 Catalog Number :

Device Description : PXB35-10-27-080 STENT VISI PRO 035 V01

Device Class : 2

Duns Number: 968903703

Premarket Exempt : No

Product Code : FGE, NIO

Prescription Use : Yes

Device Count : 1

Visi-Pro™ - 00643169788022 Catalog Number :

Device Description : PXB35-10-27-135 STENT VISI PRO 035 V01

Device Class : 2

Duns Number: 968903703

Premarket Exempt : No

Product Code : FGE, NIO

Prescription Use : Yes

Device Count : 1

Visi-Pro™ - 00643169788039 Catalog Number :

Device Description : PXB35-10-37-080 STENT VISI PRO 035 V01

Device Class : 2

Duns Number: 968903703

Premarket Exempt : No

Product Code : FGE, NIO

Prescription Use : Yes

Device Count : 1

Visi-Pro™ - 00643169788046 Catalog Number :

Device Description : PXB35-10-37-135 STENT VISI PRO 035 V01

Device Class : 2

Duns Number: 968903703

Premarket Exempt : No

Product Code : NIO, FGE

Prescription Use : Yes

Device Count : 1

Visi-Pro™ - 00643169788053 Catalog Number :

Device Description : PXB35-10-57-080 STENTVISI PRO 035 V01

Device Class : 2

Duns Number: 968903703

Premarket Exempt : No

Product Code : NIO, FGE

Prescription Use : Yes

Device Count : 1

Visi-Pro™ - 00643169788060 Catalog Number :

Device Description : PXB35-10-57-135 STENT VISI PRO 035 V01

Device Class : 2

Duns Number: 968903703

Premarket Exempt : No

Product Code : FGE, NIO

Prescription Use : Yes

Device Count : 1

HawkOne™ - 00643169792302 Catalog Number :

Device Description : ATHERECTOMY H1-M US HAWKONE V02

Device Class : 2

Duns Number: 968903703

Premarket Exempt : No

Product Code : MCW

Prescription Use : No

Device Count : 1

HawkOne™ - 00643169792319 Catalog Number :

Device Description : ATHERECTOMY H1-S US HAWKONE V02

Device Class : 2

Duns Number: 968903703

Premarket Exempt : No

Product Code : MCW

Prescription Use : No

Device Count : 1

TurboHawk™ - 00643169968202 Catalog Number :

Device Description : ATHERECTOMY THS-SS-CL TURBOHAWK BTK HECU

Device Class : 2

Duns Number: 968903703

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

TurboHawk™ - 00643169968226 Catalog Number :

Device Description : ATHERECTOMY THS-SX-C TURBOHAWK BTK HEC U

Device Class : 2

Duns Number: 968903703

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

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