STAINLESS STEEL GEN PUR INTERVENTIONAL GUIDE WIRES
FDA 510(k) clearance K914531 · decided 1992-02-27
Clearance details
- K-number
- K914531
- Device name
- STAINLESS STEEL GEN PUR INTERVENTIONAL GUIDE WIRES
- Applicant
- Arrow Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-10-11
- Decision date
- 1992-02-27
- Days to decision
- 139 days
- Clearance type
- Traditional
- Product code
- DQX
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Reading, PA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Arrow Intl.
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 |
|---|---|---|
| Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Sprin recall (Z-3299-2024) | ARROW INTERNATIONAL Inc. | 2024-09-26 |