Spectranetics Corporation

Address:9965 Federal Drive,Colorado Springs,CO,80921,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

Dilator, Vessel, For Percutaneous Catheterization (DRE) (9) Catheter, Embolectomy (DXE) (1)

Premarket Exempt

Clear

TightRail™ - M204545513AA0 Catalog Number : 545-513

Device Description : TightRail™ Rotating Dilator Sheath

Device Class : 2

Duns Number: 151047370

Premarket Exempt : No

Product Code : DRE

Prescription Use : Yes

Device Count : 1

SightRail™ - M2045500080 Catalog Number : 550-008

Device Description : SightRail™ Manual Dilator Sheath

Device Class : 2

Duns Number: 151047370

Premarket Exempt : No

Product Code : DRE

Prescription Use : Yes

Device Count : 1

SightRail™ - M2045500100 Catalog Number : 550-010

Device Description : SightRail™ Manual Dilator Sheath

Device Class : 2

Duns Number: 151047370

Premarket Exempt : No

Product Code : DRE

Prescription Use : Yes

Device Count : 1

SightRail™ - M2045500110 Catalog Number : 550-011

Device Description : SightRail™ Manual Dilator Sheath

Device Class : 2

Duns Number: 151047370

Premarket Exempt : No

Product Code : DRE

Prescription Use : Yes

Device Count : 1

SightRail™ - M2045500130 Catalog Number : 550-013

Device Description : SightRail™ Manual Dilator Sheath

Device Class : 2

Duns Number: 151047370

Premarket Exempt : No

Product Code : DRE

Prescription Use : Yes

Device Count : 1

SightRail™ - M2045555080 Catalog Number : 555-508

Device Description : SightRail™ Manual Dilator Sheath

Device Class : 2

Duns Number: 151047370

Premarket Exempt : No

Product Code : DRE

Prescription Use : Yes

Device Count : 1

SightRail™ - M2045555100 Catalog Number : 555-510

Device Description : SightRail™ Manual Dilator Sheath

Device Class : 2

Duns Number: 151047370

Premarket Exempt : No

Product Code : DRE

Prescription Use : Yes

Device Count : 1

SightRail™ - M2045555110 Catalog Number : 555-511

Device Description : SightRail™ Manual Dilator Sheath

Device Class : 2

Duns Number: 151047370

Premarket Exempt : No

Product Code : DRE

Prescription Use : Yes

Device Count : 1

SightRail™ - M2045555130 Catalog Number : 555-513

Device Description : SightRail™ Manual Dilator Sheath

Device Class : 2

Duns Number: 151047370

Premarket Exempt : No

Product Code : DRE

Prescription Use : Yes

Device Count : 1

QuickCat™ - M20460090010 Catalog Number : 60090-01

Device Description : QuickCat™ Extraction Catheter

Device Class : 2

Duns Number: 151047370

Premarket Exempt : No

Product Code : DXE

Prescription Use : Yes

Device Count : 1

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