The following data is part of a premarket notification filed by Akcess Medical Products, Inc. with the FDA for Splittable Sheath Introducer Set.
| Device ID | K920634 |
| 510k Number | K920634 |
| Device Name: | SPLITTABLE SHEATH INTRODUCER SET |
| Classification | Catheter, Subclavian |
| Applicant | AKCESS MEDICAL PRODUCTS, INC. 201 NORTH CENTER DR. New Brunswick, NJ 08902 |
| Contact | Balir B Kapany |
| Correspondent | Balir B Kapany AKCESS MEDICAL PRODUCTS, INC. 201 NORTH CENTER DR. New Brunswick, NJ 08902 |
| Product Code | LFJ |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-12 |
| Decision Date | 1994-01-14 |