Intensive Technology, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Intensive Technology, Inc.” (first 1981, latest 1993), plus 1 PMA decision, across 10 product codes in 3 review panels. Median 510(k) review time under this name: 112 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | 2 | 2 |
| DYB | Introducer, Catheter | 2 | 2 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 2 | 2 |
| DQY | Catheter, Percutaneous | 1 | 1 |
| DWX | Stripper, Artery, Intraluminal | 1 | 1 |
| GFO | Activated Partial Thromboplastin | 1 | 1 |
| JJS | Controls For Blood-Gases, (Assayed And Unassayed) | 1 | 1 |
| KFF | Assay, Heparin | 1 | 1 |
| MCW | Catheter, Peripheral, Atherectomy | 1 | 1 |
| MCX | Catheter, Coronary, Atherectomy | 1 | 0 |
Review panels
- Cardiovascular (10)
- Hematology (2)
- Clinical Chemistry (1)
Most recent Intensive Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K922970 | INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM | MCW | 1993-01-13 | 208 |
| K912664 | TEC ROTATING DUAL HEMOVALVE | DYB | 1992-08-24 | 433 |
| K911869 | IVT GUIDING CATHETER | DQY | 1991-10-16 | 173 |
| K903463 | IVT INTRODUCER SHEATH | DYB | 1991-01-03 | 155 |
| K904003 | HEMOCHRON(R) HEPARIN RESPONSE TEST | KFF | 1990-11-29 | 92 |
| K901767 | MODIFIED IVT PERIPHERAL ATHERECTOMY | LIT | 1990-06-28 | 72 |
| K896403 | MODIFIED IVT PERIPHERAL ATHERECTOMY SYSTEM | LIT | 1990-03-06 | 119 |
| K895903 | IVT 0.014 GUIDE WIRE | DQX | 1990-01-04 | 90 |
| K892209 | APTT BY HEMOCHRON(R) | GFO | 1989-06-22 | 80 |
| K890515 | PERIPHERAL ATHERECTOMY SYSTEM | DWX | 1989-05-23 | 111 |
2 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P910019 | PMA | IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R) | 1993-05-18 |
Recalls
openFDA lists no recalls under a recalling firm named Intensive Technology, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Intensive Technology, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Intensive Technology, Inc.” (first 1981, latest 1993), plus 1 PMA decision, across 10 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Intensive Technology, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Intensive Technology, Inc. is 112 days.
Which FDA product codes appear under Intensive Technology, Inc.?
The most frequent FDA product codes under this applicant name are DQX (Wire, Guide, Catheter, 2); DYB (Introducer, Catheter, 2); LIT (Catheter, Angioplasty, Peripheral, Transluminal, 2).
Next steps
- See all 12 Intensive Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQX, Intensive Technology, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.