The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Doc-tite(tm) Guide Wire Extension.
Device ID | K931171 |
510k Number | K931171 |
Device Name: | DOC-TITE(TM) GUIDE WIRE EXTENSION |
Classification | Wire, Guide, Catheter |
Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. P.O. BOX 58167 Santa Clara, CA 95052 -8167 |
Contact | Sara Toylo |
Correspondent | Sara Toylo ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. P.O. BOX 58167 Santa Clara, CA 95052 -8167 |
Product Code | DQX |
CFR Regulation Number | 870.1330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-08 |
Decision Date | 1993-06-04 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08717648013317 | K931171 | 000 |