The following data is part of a premarket notification filed by Carbomedics, Inc. with the FDA for Vascutek Graft Sizer Set.
| Device ID | K955588 |
| 510k Number | K955588 |
| Device Name: | VASCUTEK GRAFT SIZER SET |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | CARBOMEDICS, INC. 1300 EAST ANDERSON LN. Austin, TX 78752 -1793 |
| Contact | Edward E Newton |
| Correspondent | Edward E Newton CARBOMEDICS, INC. 1300 EAST ANDERSON LN. Austin, TX 78752 -1793 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-07 |
| Decision Date | 1996-03-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05037881038902 | K955588 | 000 |