The following data is part of a premarket notification filed by Parker Hannifin Corp. with the FDA for Cleveland Multiport Ventricular Catheter Set.
| Device ID | K161731 |
| 510k Number | K161731 |
| Device Name: | Cleveland Multiport Ventricular Catheter Set |
| Classification | Catheter, Ventricular |
| Applicant | Parker Hannifin Corp. 3007 Bunsen Ave. Ventura, CA 93003 |
| Contact | George Austria |
| Correspondent | Lisa Michels Parker Hannifin Corp. 10411 Corporate Drive Suite 102 Pleasant Prairie, WI 53158 |
| Product Code | HCA |
| CFR Regulation Number | 882.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-23 |
| Decision Date | 2017-03-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860002624914 | K161731 | 000 |