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 |