Atlas FDA

BARD INLAYOPTIMA URETERAL STENT WITH SUTURE

FDA 510(k) clearance K043193 · decided 2004-12-07

Clearance details

K-number
K043193
Device name
BARD INLAYOPTIMA URETERAL STENT WITH SUTURE
Applicant
C.R. Bard, Inc.
Decision
Substantially Equivalent
Date received
2004-11-18
Decision date
2004-12-07
Days to decision
19 days
Clearance type
Special
Product code
FAD
Device class
2
Regulation number
876.4620
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Covington, GA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614 recall (Z-0905-2026)C.R. Bard Inc2025-12-11
BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426 recall (Z-0906-2026)C.R. Bard Inc2025-12-11
BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630 recall (Z-0907-2026)C.R. Bard Inc2025-12-11
BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826 recall (Z-0908-2026)C.R. Bard Inc2025-12-11

PMA approvals by this applicant

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Covera™ Vascular Covered Stent (P170042/S014)C.R. Bard, Inc.2025-12-16
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Avitene Microfibrillar Collagen Hemostat (P800002/S033)C.R. Bard, Inc.2025-03-13
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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