The following data is part of a premarket notification filed by Accurate Surgical Instruments Co. with the FDA for Swan-neck Peritoneal Dialysis Catheters.
| Device ID | K862046 |
| 510k Number | K862046 |
| Device Name: | SWAN-NECK PERITONEAL DIALYSIS CATHETERS |
| Classification | Catheter, Peritoneal, Long-term Indwelling |
| Applicant | ACCURATE SURGICAL INSTRUMENTS CO. 590 RICHMOND STREET WEST Toronto Canado M5v 1y9, CA M5v 1y9 |
| Contact | Rothman |
| Correspondent | 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 | 1986-05-29 |
| Decision Date | 1986-06-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521004610 | K862046 | 000 |
| 10884521086876 | K862046 | 000 |
| 10884521004597 | K862046 | 000 |
| 10884521004603 | K862046 | 000 |
| 20884521004679 | K862046 | 000 |
| 10884521004733 | K862046 | 000 |
| 20884521198002 | K862046 | 000 |
| 10884521004429 | K862046 | 000 |
| 10884521004450 | K862046 | 000 |
| 10884521004467 | K862046 | 000 |
| 10884521004481 | K862046 | 000 |
| 10884521004504 | K862046 | 000 |
| 10884521004405 | K862046 | 000 |
| 10884521084506 | K862046 | 000 |
| 10884521084520 | K862046 | 000 |
| 10884521086852 | K862046 | 000 |