IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R)
FDA premarket approval P910019/S004 · decided 1998-12-30
Approval details
- PMA number
- P910019
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R)
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Intensive Technology, Inc.
- Date received
- 1997-10-30
- Decision date
- 1998-12-30
- Days to decision
- 426 days
- Decision code
- APPR
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- Approval for a change to the TEC System Power Pack circuitry involving the replacement of the current analog motor control circuitry (integrated circuit, LM1014N-2) with new digital circuitry (integrated circuit microcontroller, PIC16C711).
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM (K922970) | Intensive Technology, Inc. | 1993-01-13 |
| TEC ROTATING DUAL HEMOVALVE (K912664) | Intensive Technology, Inc. | 1992-08-24 |
| IVT GUIDING CATHETER (K911869) | Intensive Technology, Inc. | 1991-10-16 |
| IVT INTRODUCER SHEATH (K903463) | Intensive Technology, Inc. | 1991-01-03 |
| HEMOCHRON(R) HEPARIN RESPONSE TEST (K904003) | Intensive Technology, Inc. | 1990-11-29 |
| MODIFIED IVT PERIPHERAL ATHERECTOMY (K901767) | Intensive Technology, Inc. | 1990-06-28 |
| MODIFIED IVT PERIPHERAL ATHERECTOMY SYSTEM (K896403) | Intensive Technology, Inc. | 1990-03-06 |
| IVT 0.014 GUIDE WIRE (K895903) | Intensive Technology, Inc. | 1990-01-04 |