The following data is part of a premarket notification filed by Rex Medical with the FDA for Inner-lock Locking Introducer Sheaths.
| Device ID | K022170 |
| 510k Number | K022170 |
| Device Name: | INNER-LOCK LOCKING INTRODUCER SHEATHS |
| Classification | Introducer, Catheter |
| Applicant | REX MEDICAL 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk REX MEDICAL 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-03 |
| Decision Date | 2003-01-21 |
| Summary: | summary |