The following data is part of a premarket notification filed by Navilyst Medical, Inc. with the FDA for Picc Maximal Barrier Nursing Kit.
| Device ID | K163452 |
| 510k Number | K163452 |
| Device Name: | PICC Maximal Barrier Nursing Kit |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | Navilyst Medical, Inc. 26 Forest Street Marlborough, MA 01752 |
| Contact | Robin Fuller |
| Correspondent | Robin Fuller Navilyst Medical, Inc. 26 Forest Street Marlborough, MA 01752 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-09 |
| Decision Date | 2017-02-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H965750670 | K163452 | 000 |
| H965750480 | K163452 | 000 |
| H965750470 | K163452 | 000 |
| H965750460 | K163452 | 000 |
| H965750450 | K163452 | 000 |
| H965750440 | K163452 | 000 |
| H965750710 | K163452 | 000 |
| H965750700 | K163452 | 000 |
| H965750690 | K163452 | 000 |
| H965750680 | K163452 | 000 |
| H965460290 | K163452 | 000 |
| H965460280 | K163452 | 000 |
| H965460270 | K163452 | 000 |
| H965460260 | K163452 | 000 |
| H965460250 | K163452 | 000 |
| H965460240 | K163452 | 000 |
| H965460230 | K163452 | 000 |
| H965750490 | K163452 | 000 |
| H965750500 | K163452 | 000 |
| H965750660 | K163452 | 000 |
| H965750650 | K163452 | 000 |
| H965750640 | K163452 | 000 |
| H965750630 | K163452 | 000 |
| H965750620 | K163452 | 000 |
| H965750610 | K163452 | 000 |
| H965750600 | K163452 | 000 |
| H965750590 | K163452 | 000 |
| H965750580 | K163452 | 000 |
| H965750570 | K163452 | 000 |
| H965750560 | K163452 | 000 |
| H965750550 | K163452 | 000 |
| H965750540 | K163452 | 000 |
| H965750530 | K163452 | 000 |
| H965750520 | K163452 | 000 |
| H965750510 | K163452 | 000 |
| H965460220 | K163452 | 000 |