The following data is part of a premarket notification filed by Ascent Healthcare Solutions with the FDA for Vanguard Reprocessed Suture Passer.
| Device ID | K053585 |
| 510k Number | K053585 |
| Device Name: | VANGUARD REPROCESSED SUTURE PASSER |
| Classification | Laparoscope, General & Plastic Surgery, Reprocessed |
| Applicant | ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
| Contact | Moira Barton |
| Correspondent | Moira Barton ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST ST. Phoenix, AZ 85044 |
| Product Code | NLM |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-23 |
| Decision Date | 2006-10-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30885825013319 | K053585 | 000 |