The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Steerable Introducer.
| Device ID | K152090 |
| 510k Number | K152090 |
| Device Name: | Reprocessed Steerable Introducer |
| Classification | Reprocessed Catheter Introducer |
| Applicant | STERILMED, INC. 5010 Cheshire Parkway N, Suite 2 Plymouth, MN 55446 |
| Contact | Patricia Kaufman |
| Correspondent | Ming Cheng Chew Libra Medical Inc. 8401 63rd Avenue North, Suite 63 Brooklyn Park, MN 55428 |
| Product Code | PNE |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-27 |
| Decision Date | 2016-03-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888551044950 | K152090 | 000 |
| 10888551044929 | K152090 | 000 |
| 10888551044912 | K152090 | 000 |