The following data is part of a premarket notification filed by Ideal Medical, Inc. with the FDA for Vessel Dilator And Introducer Sheath.
| Device ID | K882238 |
| 510k Number | K882238 |
| Device Name: | VESSEL DILATOR AND INTRODUCER SHEATH |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | IDEAL MEDICAL, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater, FL 34622 |
| Contact | Lorna K Linville |
| Correspondent | Lorna K Linville IDEAL MEDICAL, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater, FL 34622 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-27 |
| Decision Date | 1988-08-25 |