The following data is part of a premarket notification filed by Access Vascular, Inc with the FDA for Hydropicc (picc-142).
| Device ID | K193015 |
| 510k Number | K193015 |
| Device Name: | HydroPICC (PICC-142) |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | Access Vascular, Inc 175 Middlesex Turnpike Suite 1A Bedford, MA 01730 |
| Contact | Brian Hanley |
| Correspondent | Brian Hanley Access Vascular, Inc 175 Middlesex Turnpike Suite 1A Bedford, MA 01730 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-29 |
| Decision Date | 2020-02-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00862559000418 | K193015 | 000 |
| 00850030354297 | K193015 | 000 |
| 00850030354303 | K193015 | 000 |
| 00850030354372 | K193015 | 000 |
| 00850030354228 | K193015 | 000 |
| 00850030354235 | K193015 | 000 |
| 00850030354242 | K193015 | 000 |
| 00862559000470 | K193015 | 000 |
| 00862559000456 | K193015 | 000 |
| 00862559000463 | K193015 | 000 |
| 00862559000487 | K193015 | 000 |
| 00862559000494 | K193015 | 000 |
| 00862559000425 | K193015 | 000 |
| 00850030354280 | K193015 | 000 |