FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
MEDTRONIC, INC. RACER BILIARY STENT SYSTEM (RACER), MODEL XD#YF(L)
K Number: K032768
·
Decision Oct 9, 2003
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
473
Applicant Total
13
Review Days
31
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Basic Information
- Device Name
- MEDTRONIC, INC. RACER BILIARY STENT SYSTEM (RACER), MODEL XD#YF(L)
- K Number
- K032768
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Medtronic Ave, Inc.
- Date Received
- September 8, 2003
- Decision Date
- October 9, 2003
- Product Code
- FGE
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Medtronic Ave, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K030633 | MEDTRONIC AVE BRIDGE CONSTANT BILIARY STENT SYSTEM OR ('CONSTANT | Sep 2, 2003 | Unknown |
| K030839 | MEDTRONIC AVE BRIDGE AURORA BILIARY STENT SYSTEM (AURORA) | May 30, 2003 | Unknown |
| K022026 | MEDTRONIC AVE BRIDGE POLARIS BILIARY STENT SYSTEM (POLARIS) | Jul 19, 2002 | Unknown |
| K014205 | MODIFICATION TO BRIDGE SELF-EXPANDING BILIARY STENT DELIVERY SYSTEM (BRIDGE SE) | Jan 14, 2002 | Unknown |
| K011080 | BRIDGE SE SELF-EXPANDING STENT DELIVERY SYSTEM | Oct 11, 2001 | Unknown |
| K011817 | BRIDGE FX | Aug 22, 2001 | Unknown |
| K002346 | WIRE, GUIDE, CATHETER, MODEL QSW1000 | Sep 27, 2000 | Substantially Equivalent |
| K994141 | CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY, MODEL SOL 3510; WIRE, GUIDE, CATHETER, MODEL QSW1000 | Jul 21, 2000 | Substantially Equivalent |
| K000744 | MEDTRONIC AVE BRIDGE X3 STENT | Jun 5, 2000 | Unknown |
| K993145 | MEDTRONIC AVE BRIDGE STENT | Oct 21, 1999 | Unknown |