The following data is part of a premarket notification filed by Applied Medical Resources with the FDA for Dual Lumen Embolectomy Catheter.
| Device ID | K970762 |
| 510k Number | K970762 |
| Device Name: | DUAL LUMEN EMBOLECTOMY CATHETER |
| Classification | Catheter, Embolectomy |
| Applicant | APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills, CA 92653 |
| Contact | Howard V Rowe |
| Correspondent | Howard V Rowe APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills, CA 92653 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-03 |
| Decision Date | 1997-03-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840663109944 | K970762 | 000 |
| 00840663109937 | K970762 | 000 |
| 00840663109920 | K970762 | 000 |
| 00840663109913 | K970762 | 000 |
| 00840663109906 | K970762 | 000 |
| 00840663109890 | K970762 | 000 |
| 00840663109883 | K970762 | 000 |
| 00840663109876 | K970762 | 000 |
| 00840663109869 | K970762 | 000 |