The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for .010 Hi-torque Guide Wires With Preshaped Tip.
Device ID | K911460 |
510k Number | K911460 |
Device Name: | .010 HI-TORQUE GUIDE WIRES WITH PRESHAPED TIP |
Classification | Wire, Guide, Catheter |
Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. P.O. BOX 58167 Santa Clara, CA 95052 -8167 |
Contact | Jane E Beggs |
Correspondent | Jane E Beggs 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 | 1991-04-03 |
Decision Date | 1991-06-25 |