The following data is part of a premarket notification filed by Phase Medical Systems, Inc. with the FDA for Safecath.
| Device ID | K880260 |
| 510k Number | K880260 |
| Device Name: | SAFECATH |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | PHASE MEDICAL SYSTEMS, INC. 3613 W. MACARTHUR BLVD. SUITE 612 Santa Ana, CA 92704 |
| Contact | Walter E Cover |
| Correspondent | Walter E Cover PHASE MEDICAL SYSTEMS, INC. 3613 W. MACARTHUR BLVD. SUITE 612 Santa Ana, CA 92704 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-22 |
| Decision Date | 1988-04-19 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SAFECATH 73741680 not registered Dead/Abandoned |
MEDICORP S.A. 1988-07-22 |