FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
OMNILINK .018 BILIARY STENT SYSTEM
K Number: K033834
·
Decision Jan 2, 2004
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
473
Applicant Total
71
Review Days
23
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Basic Information
- Device Name
- OMNILINK .018 BILIARY STENT SYSTEM
- K Number
- K033834
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Guidant Corp.
- Date Received
- December 10, 2003
- Decision Date
- January 2, 2004
- 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 Guidant Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K061865 | FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05 | Jul 27, 2006 | Substantially Equivalent |
| K061453 | HI-TORQUE WHISPER VIEW GUIDE WIRE | Jun 22, 2006 | Substantially Equivalent |
| K042908 | RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM | Nov 12, 2004 | Substantially Equivalent |
| K042218 | ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTECTION SYSTEM | Aug 31, 2004 | Substantially Equivalent |
| K033393 | ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM | Nov 10, 2003 | Unknown |
| K031678 | HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING | Aug 26, 2003 | Substantially Equivalent |
| K031459 | RAPIDO CUT-AWAY CUTTER | Jul 23, 2003 | Substantially Equivalent |
| K031398 | IS-1 HEMOSTASIS VALVE, MODEL 6799 | May 20, 2003 | Substantially Equivalent |
| K030512 | GUIDANT VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM | May 14, 2003 | Substantially Equivalent |
| K030019 | MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE | Jan 24, 2003 | Substantially Equivalent |