The following data is part of a premarket notification filed by Pilling Weck Surgical with the FDA for Pilling Weck Surgical Aortic Spoon-jaw Clamp.
| Device ID | K992174 |
| 510k Number | K992174 |
| Device Name: | PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP |
| Classification | Clamp, Vascular |
| Applicant | PILLING WECK SURGICAL 420 DELAWARE DR. Fort Washington, PA 19034 |
| Contact | Richard G Jones |
| Correspondent | Richard G Jones PILLING WECK SURGICAL 420 DELAWARE DR. Fort Washington, PA 19034 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-28 |
| Decision Date | 2000-03-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04026704521654 | K992174 | 000 |
| 04026704520121 | K992174 | 000 |
| 04026704520138 | K992174 | 000 |
| 04026704520145 | K992174 | 000 |
| 04026704520169 | K992174 | 000 |
| 04026704520176 | K992174 | 000 |
| 04026704520497 | K992174 | 000 |
| 04026704520503 | K992174 | 000 |
| 04026704520510 | K992174 | 000 |
| 04026704520848 | K992174 | 000 |
| 04026704521234 | K992174 | 000 |
| 04026704521241 | K992174 | 000 |
| 04026704521258 | K992174 | 000 |
| 04026704520114 | K992174 | 000 |