The following data is part of a premarket notification filed by Cardio Flow, Inc. with the FDA for Cardio Flow Peripheral Guide Wire.
| Device ID | K213834 |
| 510k Number | K213834 |
| Device Name: | Cardio Flow Peripheral Guide Wire |
| Classification | Wire, Guide, Catheter |
| Applicant | Cardio Flow, Inc. 888 East Avenue Mahtomedi, MN 55115 |
| Contact | Michael J. Kallok |
| Correspondent | Michael J Kallok Quality & Regulatory Associates, LLC 888 East Evenuse Mahtomedi, MN 55115 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-09 |
| Decision Date | 2022-03-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850040691023 | K213834 | 000 |