The following data is part of a premarket notification filed by Hollister Incorporated with the FDA for Vapro 2 Intermittent Catheter.
| Device ID | K180824 |
| 510k Number | K180824 |
| Device Name: | VaPro 2 Intermittent Catheter |
| Classification | Catheter, Urethral |
| Applicant | Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048 |
| Contact | Michelle Schiltz-taing |
| Correspondent | Michelle Schiltz-taing Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048 |
| Product Code | GBM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-30 |
| Decision Date | 2018-06-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00610075067985 | K180824 | 000 |
| 00610075067978 | K180824 | 000 |
| 00610075067893 | K180824 | 000 |
| 00610075067787 | K180824 | 000 |