The following data is part of a premarket notification filed by Pfm Medical, Inc with the FDA for Picc (ct Rated And Non-rated).
| Device ID | K083873 |
| 510k Number | K083873 |
| Device Name: | PICC (CT RATED AND NON-RATED) |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | PFM MEDICAL, INC 2605 TEMPLE HEIGHTS DRIVE SUITE A Oceanside, CA 92056 |
| Contact | Salvadore Palomares |
| Correspondent | Salvadore Palomares PFM MEDICAL, INC 2605 TEMPLE HEIGHTS DRIVE SUITE A Oceanside, CA 92056 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-29 |
| Decision Date | 2009-03-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813623040649 | K083873 | 000 |
| 20813623013630 | K083873 | 000 |
| 20813623013647 | K083873 | 000 |
| 20813623013654 | K083873 | 000 |
| 20813623013692 | K083873 | 000 |
| 20813623013708 | K083873 | 000 |
| 20813623013715 | K083873 | 000 |
| 20813623013722 | K083873 | 000 |
| 20813623013739 | K083873 | 000 |
| 20813623013623 | K083873 | 000 |
| 20813623013609 | K083873 | 000 |
| 04046964310546 | K083873 | 000 |
| 04046964310584 | K083873 | 000 |
| 04046964310621 | K083873 | 000 |
| 04046964310669 | K083873 | 000 |
| 04046964310690 | K083873 | 000 |
| 04046964310737 | K083873 | 000 |
| 04046964310775 | K083873 | 000 |
| 04046964310812 | K083873 | 000 |
| 20813623013753 | K083873 | 000 |
| 20813623013760 | K083873 | 000 |
| 20813623018512 | K083873 | 000 |
| 20813623018529 | K083873 | 000 |
| 20813623018536 | K083873 | 000 |
| 20813623018543 | K083873 | 000 |
| 20813623018574 | K083873 | 000 |
| 20813623018581 | K083873 | 000 |
| 20813623018802 | K083873 | 000 |
| 20813623040612 | K083873 | 000 |
| 20813623018505 | K083873 | 000 |
| 20813623018055 | K083873 | 000 |
| 20813623013777 | K083873 | 000 |
| 20813623017430 | K083873 | 000 |
| 20813623017454 | K083873 | 000 |
| 20813623017461 | K083873 | 000 |
| 20813623017478 | K083873 | 000 |
| 20813623017485 | K083873 | 000 |
| 20813623017492 | K083873 | 000 |
| 20813623018048 | K083873 | 000 |
| 20813623010172 | K083873 | 000 |