The following data is part of a premarket notification filed by Pfm Medical, Inc with the FDA for Veta Peritoneal Dialysis Catheter.
| Device ID | K113354 |
| 510k Number | K113354 |
| Device Name: | VETA PERITONEAL DIALYSIS CATHETER |
| Classification | Catheter, Peritoneal, Long-term Indwelling |
| Applicant | PFM MEDICAL, INC 1815 ASTON AVE SUITE 106 Carlsbad, CA 92008 |
| Contact | Salvadore Palomares |
| Correspondent | Salvadore Palomares PFM MEDICAL, INC 1815 ASTON AVE SUITE 106 Carlsbad, CA 92008 |
| Product Code | FJS |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-14 |
| Decision Date | 2012-03-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10813623040523 | K113354 | 000 |
| 20813623019243 | K113354 | 000 |
| 10813623016092 | K113354 | 000 |
| 10813623016085 | K113354 | 000 |
| 10813623016078 | K113354 | 000 |
| 20813623015702 | K113354 | 000 |