The following data is part of a premarket notification filed by Luther Medical Products, Inc. with the FDA for L-cath Peel Away System Catheter.
| Device ID | K920755 |
| 510k Number | K920755 |
| Device Name: | L-CATH PEEL AWAY SYSTEM CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | LUTHER MEDICAL PRODUCTS, INC. 14332 CHAMBERS RD. Tustin, CA 92780 -6912 |
| Contact | Barbara C Luther |
| Correspondent | Barbara C Luther LUTHER MEDICAL PRODUCTS, INC. 14332 CHAMBERS RD. Tustin, CA 92780 -6912 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-19 |
| Decision Date | 1993-06-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20886333209594 | K920755 | 000 |