FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
RX HERCULINK ELITE BILIARY STENT SYSTEM
K Number: K053454
·
Decision Mar 6, 2006
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
473
Applicant Total
15
Review Days
87
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Basic Information
- Device Name
- RX HERCULINK ELITE BILIARY STENT SYSTEM
- K Number
- K053454
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Guidant Corporation
- Date Received
- December 9, 2005
- Decision Date
- March 6, 2006
- 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 Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K060449 | HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE | May 30, 2006 | Substantially Equivalent |
| K053459 | OMNILINK .035 BILIARY STENT SYSTEM | Apr 12, 2006 | Unknown |
| K053019 | ACUITY STEERABLE STYLET ACCESSORY | Mar 3, 2006 | Substantially Equivalent |
| K052965 | EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832. | Feb 13, 2006 | Substantially Equivalent |
| K052274 | GUIDANT VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-3000 | Sep 21, 2005 | Substantially Equivalent |
| K052166 | MODIFICATION TO: RX ACCUNET EMBOLIC PROTECTION SYSTEM | Aug 18, 2005 | Substantially Equivalent |
| K052165 | RX ACCUNET EMBOLIC PROTECTION SYSTEM | Aug 16, 2005 | Substantially Equivalent |
| K041981 | GUIDANT VASOVIEW 6 HARVESTING CANNULA, MODEL VH-2000; GUIDANT VASOVIEW 6 ACCESSORY PACK, MODEL VH-2004 | Aug 20, 2004 | Substantially Equivalent |
| K041762 | FINISHING WIRE SUPPORTRAK | Aug 6, 2004 | Substantially Equivalent |
| K041574 | CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020 | Jul 12, 2004 | Substantially Equivalent |