The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Acs Hi-torque Extra S'port(tm) Guide Wire.
| Device ID | K950156 |
| 510k Number | K950156 |
| Device Name: | ACS HI-TORQUE EXTRA S'PORT(TM) GUIDE WIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. P.O. BOX 58167 Santa Clara, CA 95052 -8167 |
| Contact | J P Palin |
| Correspondent | J P Palin 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 | 1995-01-17 |
| Decision Date | 1995-04-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 28717648079614 | K950156 | 000 |
| 08717648079603 | K950156 | 000 |
| 28717648079591 | K950156 | 000 |
| 28717648079584 | K950156 | 000 |
| 28717648079577 | K950156 | 000 |