The following data is part of a premarket notification filed by Medical Profiles, Inc. with the FDA for Peripheral Intervenous Catheter.
| Device ID | K914378 |
| 510k Number | K914378 |
| Device Name: | PERIPHERAL INTERVENOUS CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | MEDICAL PROFILES, INC. 13324 FARMINGTON RD. Lavonia, MI 48150 |
| Contact | Michael Mcavenia |
| Correspondent | Michael Mcavenia MEDICAL PROFILES, INC. 13324 FARMINGTON RD. Lavonia, MI 48150 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-01 |
| Decision Date | 1993-05-20 |