Intensive Technology, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 12
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K922970 | INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM | January 13, 1993 |
| K912664 | TEC ROTATING DUAL HEMOVALVE | August 24, 1992 |
| K911869 | IVT GUIDING CATHETER | October 16, 1991 |
| K903463 | IVT INTRODUCER SHEATH | January 3, 1991 |
| K904003 | HEMOCHRON(R) HEPARIN RESPONSE TEST | November 29, 1990 |
| K901767 | MODIFIED IVT PERIPHERAL ATHERECTOMY | June 28, 1990 |
| K896403 | MODIFIED IVT PERIPHERAL ATHERECTOMY SYSTEM | March 6, 1990 |
| K895903 | IVT 0.014 GUIDE WIRE | January 4, 1990 |
| K892209 | APTT BY HEMOCHRON(R) | June 22, 1989 |
| K890515 | PERIPHERAL ATHERECTOMY SYSTEM | May 23, 1989 |
| K882804 | 0.014 PERIPHERAL GUIDE WIRE | October 28, 1988 |
| K810107 | RESPA-TROL | January 26, 1981 |