The following data is part of a premarket notification filed by Freudenberg Medical Llc with the FDA for Steerable Introducer.
| Device ID | K191190 |
| 510k Number | K191190 |
| Device Name: | Steerable Introducer |
| Classification | Introducer, Catheter |
| Applicant | Freudenberg Medical LLC 2301 Centennial Boulevard Jeffersonville, IN 47130 |
| Contact | Mary Prunty |
| Correspondent | Mary Prunty Freudenberg Medical LLC 2301 Centennial Boulevard Jeffersonville, IN 47130 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-03 |
| Decision Date | 2019-08-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850004312032 | K191190 | 000 |
| 00850004312025 | K191190 | 000 |
| 00850004312018 | K191190 | 000 |