The following data is part of a premarket notification filed by Aeroquip Medical Products with the FDA for Aeroquip Safestart (tm) Iv Cath (tm) System.
| Device ID | K970644 |
| 510k Number | K970644 |
| Device Name: | AEROQUIP SAFESTART (TM) IV CATH (TM) SYSTEM |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | AEROQUIP MEDICAL PRODUCTS 2323 GREEN RD. Ann Arbor, MI 48105 |
| Contact | Christina L Thomas |
| Correspondent | Christina L Thomas AEROQUIP MEDICAL PRODUCTS 2323 GREEN RD. Ann Arbor, MI 48105 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-20 |
| Decision Date | 1997-07-31 |