Bard Conformexx Biliary Stent with the Performaxx Grip
FDA 510(k) K052114 · Bard Peripheral Vascular, Inc.
510(k) numberK052114
Submission
- Device name
- Bard Conformexx Biliary Stent with the Performaxx Grip
- Applicant
- Bard Peripheral Vascular, Inc.
Tempe, AZ, US - Received
- August 4, 2005
- Decision date
- August 25, 2005
- Decision
- Unknown (SESU)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FGE – Stents, Drains And Dilators For The Biliary Ducts
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5010
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
- Life-sustaining
- Yes
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Questions and answers
When was Bard Conformexx Biliary Stent with the Performaxx Grip cleared by the FDA?
Bard Conformexx Biliary Stent with the Performaxx Grip (K052114) received a 510(k) decision of Unknown on August 25, 2005, 21 days after the submission was received.
What is the product code of K052114?
The FDA product code is FGE – Stents, Drains And Dilators For The Biliary Ducts, a Class II (moderate risk) device regulated under 21 CFR 876.5010.