The following data is part of a premarket notification filed by Halyard Health with the FDA for On-q* Pump With Bolus.
| Device ID | K181360 |
| 510k Number | K181360 |
| Device Name: | ON-Q* Pump With Bolus |
| Classification | Pump, Infusion, Elastomeric |
| Applicant | Halyard Health 43 Discovery, Suite 100 Irvine, CA 92618 |
| Contact | Neerav Parikh |
| Correspondent | Neerav Parikh Halyard Health 43 Discovery, Suite 100 Irvine, CA 92618 |
| Product Code | MEB |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-22 |
| Decision Date | 2019-03-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30680651468575 | K181360 | 000 |
| 10193494468535 | K181360 | 000 |
| 10193494468566 | K181360 | 000 |
| 10193494468573 | K181360 | 000 |
| 10193494470576 | K181360 | 000 |
| 10193494470583 | K181360 | 000 |
| 10193494470590 | K181360 | 000 |
| 10193494470606 | K181360 | 000 |
| 30680651470578 | K181360 | 000 |
| 30680651470585 | K181360 | 000 |
| 30680651470592 | K181360 | 000 |
| 30680651470608 | K181360 | 000 |
| 30680651468520 | K181360 | 000 |
| 30680651468537 | K181360 | 000 |
| 30680651468568 | K181360 | 000 |
| 10193494468528 | K181360 | 000 |