ACS VIKING GUIDING CATHETER
FDA 510(k) clearance K972484 · decided 1997-09-26
Clearance details
- K-number
- K972484
- Device name
- ACS VIKING GUIDING CATHETER
- Applicant
- Guidant Corp.
- Decision
- Substantially Equivalent
- Date received
- 1997-07-02
- Decision date
- 1997-09-26
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Santa Clara, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Guidant Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 6F Viking Guiding Catheter, Percutaneous catheter, Shape ALR 1.2, Part Number: 1001934-06, recall (Z-1633-2008) | Abbott Vascular-Cardiac Therapies dba Guidant Corporation | 2008-08-13 |
| 6F Viking Guiding Catheter, Percutaneous catheter Shape BP-L, Part Number: 1001970-06, Abb recall (Z-1634-2008) | Abbott Vascular-Cardiac Therapies dba Guidant Corporation | 2008-08-13 |