Company ยท US
Intensive Technology, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 1993. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DQX | Wire, Guide, Catheter | 2 |
| DYB | Introducer, Catheter | 2 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 2 |
| DQY | Catheter, Percutaneous | 1 |
| DWX | Stripper, Artery, Intraluminal | 1 |
| GFO | Activated Partial Thromboplastin | 1 |
| JJS | Controls For Blood-Gases, (Assayed And Unassayed) | 1 |
| KFF | Assay, Heparin | 1 |
| MCW | Catheter, Peripheral, Atherectomy | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 13, 1993 | K922970 | INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM Intensive Technology, Inc. | MCW |
| Aug 24, 1992 | K912664 | TEC ROTATING DUAL HEMOVALVE Intensive Technology, Inc. | DYB |
| Oct 16, 1991 | K911869 | IVT GUIDING CATHETER Intensive Technology, Inc. | DQY |
| Jan 3, 1991 | K903463 | IVT INTRODUCER SHEATH Intensive Technology, Inc. | DYB |
| Nov 29, 1990 | K904003 | HEMOCHRON(R) HEPARIN RESPONSE TEST Intensive Technology, Inc. | KFF |
| Jun 28, 1990 | K901767 | MODIFIED IVT PERIPHERAL ATHERECTOMY Intensive Technology, Inc. | LIT |
| Mar 6, 1990 | K896403 | MODIFIED IVT PERIPHERAL ATHERECTOMY SYSTEM Intensive Technology, Inc. | LIT |
| Jan 4, 1990 | K895903 | IVT 0.014 GUIDE WIRE Intensive Technology, Inc. | DQX |
| Jun 22, 1989 | K892209 | APTT BY HEMOCHRON(R) Intensive Technology, Inc. | GFO |
| May 23, 1989 | K890515 | PERIPHERAL ATHERECTOMY SYSTEM Intensive Technology, Inc. | DWX |
| Oct 28, 1988 | K882804 | 0.014 PERIPHERAL GUIDE WIRE Intensive Technology, Inc. | DQX |
| Jan 26, 1981 | K810107 | RESPA-TROL Intensive Technology, Inc. | JJS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||