The following data is part of a premarket notification filed by Hollister, Incorporated with the FDA for Vapro Intermittent Catheter.
| Device ID | K141642 |
| 510k Number | K141642 |
| Device Name: | VAPRO INTERMITTENT CATHETER |
| Classification | Catheter, Urethral |
| Applicant | HOLLISTER, INCORPORATED 2000 HOLLISTER DRIVE Libertyville, IL 60048 |
| Contact | Jeanne Lee |
| Correspondent | Jeanne Lee 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 | 2014-06-19 |
| Decision Date | 2014-08-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10610075176219 | K141642 | 000 |
| 00610075065417 | K141642 | 000 |
| 00610075065400 | K141642 | 000 |
| 00610075065394 | K141642 | 000 |
| 00610075065387 | K141642 | 000 |
| 00610075065370 | K141642 | 000 |
| 00610075080649 | K141642 | 000 |
| 00610075080632 | K141642 | 000 |
| 00610075080625 | K141642 | 000 |
| 00610075080618 | K141642 | 000 |
| 00610075080601 | K141642 | 000 |
| 00610075080595 | K141642 | 000 |
| 00610075065424 | K141642 | 000 |
| 00610075065431 | K141642 | 000 |
| 00610075065448 | K141642 | 000 |
| 10610075176202 | K141642 | 000 |
| 10610075176141 | K141642 | 000 |
| 10610075176134 | K141642 | 000 |
| 20610075161700 | K141642 | 000 |
| 20610075161694 | K141642 | 000 |
| 20610075161687 | K141642 | 000 |
| 00610075176212 | K141642 | 000 |
| 00610075176205 | K141642 | 000 |
| 00610075176144 | K141642 | 000 |
| 00610075176137 | K141642 | 000 |
| 00610075065455 | K141642 | 000 |
| 00610075080588 | K141642 | 000 |