Atlas FDA

ECLIPSE FILTER SYSTEM-FEMORAL DELIVERY KIT, ECLIPSE FILTER SYSTEM-JUGULAR/SUBCLAVIAN DELIVERY KIT MODEL RF500F MODEL RF5

FDA 510(k) clearance K093659 · decided 2010-01-14

Clearance details

K-number
K093659
Device name
ECLIPSE FILTER SYSTEM-FEMORAL DELIVERY KIT, ECLIPSE FILTER SYSTEM-JUGULAR/SUBCLAVIAN DELIVERY KIT MODEL RF500F MODEL RF5
Applicant
C.R. Bard, Inc.
Decision
Substantially Equivalent
Date received
2009-11-25
Decision date
2010-01-14
Days to decision
50 days
Clearance type
Special
Product code
DTK
Device class
2
Regulation number
870.3375
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Tempe, AZ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Covera™ Vascular Covered Stent (P170042/S014)C.R. Bard, Inc.2025-12-16
Covera™ Vascular Covered Stents (P170042/S013)C.R. Bard, Inc.2025-06-26
Avitene Microfibrillar Collagen Hemostat (P800002/S033)C.R. Bard, Inc.2025-03-13
AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB (P800002/S032)C.R. Bard, Inc.2025-02-18
Avitene™ Bulk Flour Cleanroom Expansion (P800002/S031)C.R. Bard, Inc.2024-01-18
Avitene™ Microfibrillar Collagen Hemostat (P800002/S030)C.R. Bard, Inc.2023-10-04
Covera™ Vascular Covered Stent (P170042/S012)C.R. Bard, Inc.2023-02-02
Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web and Avitene Microfibrillar Collagen Hemostat (MCH) EndoAvit (P800002/S027)C.R. Bard, Inc.2022-04-01