RESPA-TROL
FDA 510(k) clearance K810107 · decided 1981-01-26
Clearance details
- K-number
- K810107
- Device name
- RESPA-TROL
- Applicant
- Intensive Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-01-16
- Decision date
- 1981-01-26
- Days to decision
- 10 days
- Clearance type
- Traditional
- Product code
- JJS
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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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 |