Intensive Technology, Inc.
Mchenry, IL, US
Intensive Technology, Inc. appears in FDA device records in Mchenry, IL. FDA records list 12 510(k) clearances between and , 6 PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 12
- PMA records
- 6
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for Intensive Technology, Inc. between 1981 and 1993. The busiest year on record is 1990, with 4. The most recent is 1993, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 1 |
| 1988 | 1 |
| 1989 | 2 |
| 1990 | 4 |
| 1991 | 2 |
| 1992 | 1 |
| 1993 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K922970 | INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM | MCW | Substantially Equivalent | |
| K912664 | TEC ROTATING DUAL HEMOVALVE | DYB | Substantially Equivalent | |
| K911869 | IVT GUIDING CATHETER | DQY | Substantially Equivalent | |
| K903463 | IVT INTRODUCER SHEATH | DYB | Substantially Equivalent | |
| K904003 | HEMOCHRON(R) HEPARIN RESPONSE TEST | KFF | Substantially Equivalent | |
| K901767 | MODIFIED IVT PERIPHERAL ATHERECTOMY | LIT | Substantially Equivalent | |
| K896403 | MODIFIED IVT PERIPHERAL ATHERECTOMY SYSTEM | LIT | Substantially Equivalent | |
| K895903 | IVT 0.014 GUIDE WIRE | DQX | Substantially Equivalent | |
| K892209 | APTT BY HEMOCHRON(R) | GFO | Substantially Equivalent | |
| K890515 | PERIPHERAL ATHERECTOMY SYSTEM | DWX | Substantially Equivalent | |
| K882804 | 0.014 PERIPHERAL GUIDE WIRE | DQX | Substantially Equivalent | |
| K810107 | RESPA-TROL | JJS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GFOActivated Partial Thromboplastin
- KFFAssay, Heparin
- LITCatheter, Angioplasty, Peripheral, Transluminal
- MCXCatheter, Coronary, Atherectomy
- DQYCatheter, Percutaneous
- MCWCatheter, Peripheral, Atherectomy
- JJSControls For Blood-Gases, (Assayed And Unassayed)
- DYBIntroducer, Catheter
- DWXStripper, Artery, Intraluminal
- DQXWire, Guide, Catheter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain