The following data is part of a premarket notification filed by Heraeus Medical Components, Llc with the FDA for Heraeus Peripheral Guidewire.
| Device ID | K191502 |
| 510k Number | K191502 |
| Device Name: | Heraeus Peripheral Guidewire |
| Classification | Wire, Guide, Catheter |
| Applicant | Heraeus Medical Components, LLC 2605 Fernbrook Lane North, Suite J Plymouth, MN 55447 |
| Contact | Chelsea Pioske |
| Correspondent | Chelsea Pioske Heraeus Medical Components, LLC 2605 Fernbrook Lane North, Suite J Plymouth, MN 55447 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-06 |
| Decision Date | 2019-11-26 |
| Summary: | summary |