The following data is part of a premarket notification filed by Applied Medical Resources with the FDA for Latis Graft Cleaning Catheter.
| Device ID | K973465 |
| 510k Number | K973465 |
| Device Name: | LATIS GRAFT CLEANING CATHETER |
| Classification | Catheter, Embolectomy |
| Applicant | APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills, CA 92653 |
| Contact | Mary Jo Stegwell |
| Correspondent | Mary Jo Stegwell 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 | 1997-09-12 |
| Decision Date | 1998-02-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840663109975 | K973465 | 000 |
| 00840663109968 | K973465 | 000 |
| 00840663109951 | K973465 | 000 |