0.014 PERIPHERAL GUIDE WIRE
FDA 510(k) clearance K882804 · decided 1988-10-28
Clearance details
- K-number
- K882804
- Device name
- 0.014 PERIPHERAL GUIDE WIRE
- Applicant
- Intensive Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-07-07
- Decision date
- 1988-10-28
- Days to decision
- 113 days
- Clearance type
- Traditional
- Product code
- DQX
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Intensive Technology
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
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R) (P910019/S004) | Intensive Technology, Inc. | 1998-12-30 |
| IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R) (P910019/S005) | Intensive Technology, Inc. | 1998-02-23 |
| IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R) (P910019/S003) | Intensive Technology, Inc. | 1998-01-29 |
| IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R) (P910019/S002) | Intensive Technology, Inc. | 1996-09-17 |
| IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R) (P910019/S001) | Intensive Technology, Inc. | 1995-01-05 |
| IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R) (P910019) | Intensive Technology, Inc. | 1993-05-18 |