The following data is part of a premarket notification filed by Medtronic Xomed, Inc. with the FDA for Microfrance(r) Wormald Vascular Clamp.
| Device ID | K112662 |
| 510k Number | K112662 |
| Device Name: | MICROFRANCE(R) WORMALD VASCULAR CLAMP |
| Classification | Clamp, Vascular |
| Applicant | MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Contact | Marsha Seetaram |
| Correspondent | Marsha Seetaram MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-13 |
| Decision Date | 2012-01-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780102359 | K112662 | 000 |
| 10381780102342 | K112662 | 000 |
| 10381780102335 | K112662 | 000 |
| 10381780102328 | K112662 | 000 |
| 10381780102311 | K112662 | 000 |
| 10381780102304 | K112662 | 000 |
| 10381780539605 | K112662 | 000 |
| 10381780539582 | K112662 | 000 |