The following data is part of a premarket notification filed by Medionics International, Inc. with the FDA for Peritoneal Dialysis Catheters And Adapters.
| Device ID | K993149 |
| 510k Number | K993149 |
| Device Name: | PERITONEAL DIALYSIS CATHETERS AND ADAPTERS |
| Classification | Catheter, Peritoneal, Long-term Indwelling |
| Applicant | MEDIONICS INTERNATIONAL, INC. 114 ANDERSON AVE. Markham, Ontario, CA L6e 1a5 |
| Contact | Mashesh Agarwal |
| Correspondent | Mashesh Agarwal MEDIONICS INTERNATIONAL, INC. 114 ANDERSON AVE. Markham, Ontario, CA L6e 1a5 |
| Product Code | FJS |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-21 |
| Decision Date | 2000-04-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00792079001674 | K993149 | 000 |
| 00792079000035 | K993149 | 000 |
| 00792079000141 | K993149 | 000 |
| 00792079000196 | K993149 | 000 |
| 00792079000219 | K993149 | 000 |
| 00792079000226 | K993149 | 000 |
| 00792079000264 | K993149 | 000 |
| 00792079000356 | K993149 | 000 |
| 00792079000363 | K993149 | 000 |
| 00792079000394 | K993149 | 000 |
| 00792079000400 | K993149 | 000 |
| 00792079000592 | K993149 | 000 |
| 00792079000967 | K993149 | 000 |
| 00792079001476 | K993149 | 000 |
| 00792079000028 | K993149 | 000 |