The following data is part of a premarket notification filed by Alva Medical, Inc. with the FDA for Dilator, Vessel, For Perc. Catheter..
| Device ID | K801113 |
| 510k Number | K801113 |
| Device Name: | DILATOR, VESSEL, FOR PERC. CATHETER. |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | ALVA MEDICAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-12 |
| Decision Date | 1980-07-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450028893 | K801113 | 000 |
| 10884450026400 | K801113 | 000 |
| 10884450020002 | K801113 | 000 |
| 10884450019990 | K801113 | 000 |