The following data is part of a premarket notification filed by Accurate Surgical Instruments Co. with the FDA for Swan Neck Presternal Peritoneal Dialysis Catheter.
| Device ID | K950042 |
| 510k Number | K950042 |
| Device Name: | SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER |
| Classification | Catheter, Peritoneal, Long-term Indwelling |
| Applicant | ACCURATE SURGICAL INSTRUMENTS CO. 590 RICHMOND STREET WEST Toronto Canado M5v 1y9, CA M5v 1y9 |
| Contact | D Rothman |
| Correspondent | D Rothman ACCURATE SURGICAL INSTRUMENTS CO. 590 RICHMOND STREET WEST Toronto Canado M5v 1y9, CA M5v 1y9 |
| Product Code | FJS |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-05 |
| Decision Date | 1995-12-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521056015 | K950042 | 000 |
| 10884521004665 | K950042 | 000 |