MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG SAFETY KIT
FDA 510(k) clearance K030855 · decided 2003-04-17
Clearance details
- K-number
- K030855
- Device name
- MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG SAFETY KIT
- Applicant
- Boston Scientific Corp
- Decision
- Unknown
- Date received
- 2003-03-18
- Decision date
- 2003-04-17
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- KNT
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Natick,, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| EndoVive Safety PEG Kits 24 F Universal Product Number (UPN): MOO56648 1 The product provi recall (Z-2236-2008) | Boston Scientific Corporation | 2008-09-17 |
| EndoVive Safety PEG Kits 20 F Universal Product Number (UPN): MOO566460 The product provid recall (Z-2237-2008) | Boston Scientific Corporation | 2008-09-17 |