FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
ZILVER 518 BILIARY STENT
K Number: K033348
·
Decision Dec 15, 2003
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
473
Applicant Total
190
Review Days
56
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Basic Information
- Device Name
- ZILVER 518 BILIARY STENT
- K Number
- K033348
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Cook, Inc.
- Date Received
- October 20, 2003
- Decision Date
- December 15, 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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|---|---|---|---|
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| K133597 | CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY | Apr 18, 2014 | Substantially Equivalent |
| K131772 | CANTATA(R) 2.9 MICROCATHETER | Feb 20, 2014 | Substantially Equivalent |
| K131204 | ADVANCE CS CORONARY SINUS INFUSION CATHETER | Jan 29, 2014 | Substantially Equivalent |
| K133634 | SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET | Dec 23, 2013 | Substantially Equivalent |
| K132020 | ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER | Oct 25, 2013 | Substantially Equivalent |
| K131201 | ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SET | Oct 7, 2013 | Substantially Equivalent |
| K131206 | COOK CERVICAL RIPENING BALLOON | Sep 27, 2013 | Substantially Equivalent |