The following data is part of a premarket notification filed by Freudenberg Medical Llc with the FDA for Steerable Introducer 12f.
| Device ID | K192422 |
| 510k Number | K192422 |
| Device Name: | Steerable Introducer 12F |
| Classification | Catheter, Steerable |
| Applicant | Freudenberg Medical LLC 2301 Centennial Boulevard Jeffersonville, IN 47130 |
| Contact | Mary Prunty |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DRA |
| CFR Regulation Number | 870.1280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-09-04 |
| Decision Date | 2019-10-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850004312049 | K192422 | 000 |