The following data is part of a premarket notification filed by Intramed Laboratories, Inc. with the FDA for Graft Thrombectomy Instruments.
| Device ID | K942457 |
| 510k Number | K942457 |
| Device Name: | GRAFT THROMBECTOMY INSTRUMENTS |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | INTRAMED LABORATORIES, INC. 11100 ROSELLE ST. San Diego, CA 92121 |
| Contact | R Alden Kay |
| Correspondent | R Alden Kay INTRAMED LABORATORIES, INC. 11100 ROSELLE ST. San Diego, CA 92121 |
| Product Code | MCW |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-24 |
| Decision Date | 1995-02-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103043570 | K942457 | 000 |
| 00690103043563 | K942457 | 000 |