Intec Medical, Inc.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Intec Medical, Inc.” (first 1980, latest 1991), across 11 product codes in 3 review panels. Median 510(k) review time under this name: 50 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 |
|---|---|---|---|
| DQY | Catheter, Percutaneous | 3 | 3 |
| BYX | Tubing, Pressure And Accessories | 2 | 2 |
| BZA | Connector, Airway (Extension) | 2 | 2 |
| DYB | Introducer, Catheter | 2 | 2 |
| DYG | Catheter, Flow Directed | 2 | 2 |
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | 1 | 1 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 1 | 1 |
| CAF | Nebulizer (Direct Patient Interface) | 1 | 1 |
| EZN | Dilator, Catheter, Ureteral | 1 | 1 |
| KRB | Probe, Thermodilution | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Intec Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K911840 | INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETER | DYG | 1991-06-03 | 39 |
| K903217 | TAPERED TIP THE GUIDER CORONARY GUIDING CATHETER | DQY | 1990-10-19 | 88 |
| K903216 | THE GUIDER CORONARY GUIDING CATHETER | DQY | 1990-10-19 | 88 |
| K900710 | INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER | KRB | 1990-10-19 | 247 |
| K903840 | GIANT LUMEN SAFETIP SERIES: ENDOMYOCARDIAL BIOPSY | DYB | 1990-10-16 | 56 |
| K903906 | PERCUTANEOUS CATHETER INTRODUCER KIT | DYB | 1990-09-26 | 34 |
| K900998 | INTERVENTIONAL MEDICAL Y ADAPTER W/ADJUST. VALVE | DQY | 1990-08-14 | 166 |
| K901247 | TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES | DYG | 1990-07-31 | 138 |
| K894925 | AMCATH URETERAL DILATORS MODELS 7100,7110,7120 | EZN | 1989-12-13 | 133 |
| K860941 | DISPOSABLE HEATED WIRE LOOPS 48 AND 72 | BZE | 1986-04-02 | 21 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Intec Medical, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Intec Medical, Inc. (a text match, not an official crosswalk):
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Intec. (3 510(k)s)
- Intec Industries, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Intec Medical, Inc.?
FDA lists 17 510(k) clearances under the applicant name “Intec Medical, Inc.” (first 1980, latest 1991), across 11 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 Intec Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Intec Medical, Inc. is 50 days.
Which FDA product codes appear under Intec Medical, Inc.?
The most frequent FDA product codes under this applicant name are DQY (Catheter, Percutaneous, 3); BYX (Tubing, Pressure And Accessories, 2); BZA (Connector, Airway (Extension), 2).
Next steps
- See all 17 Intec Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQY, Intec Medical, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.