Intec Medical, Inc.
Blue Springs, MO, US
Intec Medical, Inc. appears in FDA device records in Blue Springs, MO. FDA records list 17 510(k) clearances between and , no 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
- 17
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 17 510(k) clearances for Intec Medical, Inc. between 1980 and 1991. The busiest year on record is 1990, with 7. The most recent is 1991, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 3 |
| 1981 | 2 |
| 1982 | 2 |
| 1986 | 1 |
| 1989 | 1 |
| 1990 | 7 |
| 1991 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K911840 | INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETER | DYG | Substantially Equivalent | |
| K903217 | TAPERED TIP THE GUIDER CORONARY GUIDING CATHETER | DQY | Substantially Equivalent | |
| K903216 | THE GUIDER CORONARY GUIDING CATHETER | DQY | Substantially Equivalent | |
| K900710 | INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER | KRB | Substantially Equivalent | |
| K903840 | GIANT LUMEN SAFETIP SERIES: ENDOMYOCARDIAL BIOPSY | DYB | Substantially Equivalent | |
| K903906 | PERCUTANEOUS CATHETER INTRODUCER KIT | DYB | Substantially Equivalent | |
| K900998 | INTERVENTIONAL MEDICAL Y ADAPTER W/ADJUST. VALVE | DQY | Substantially Equivalent | |
| K901247 | TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES | DYG | Substantially Equivalent | |
| K894925 | AMCATH URETERAL DILATORS MODELS 7100,7110,7120 | EZN | Substantially Equivalent | |
| K860941 | DISPOSABLE HEATED WIRE LOOPS 48 AND 72 | BZE | Substantially Equivalent | |
| K823271 | DISPOSABLE ADULT VO. VENTILATOR CIRCUIT | BZO | Substantially Equivalent | |
| K813317 | DISP. HYPERINFLATION BAG SYSTEM | NHK | Substantially Equivalent | |
| K810621 | DISPOSABLE 22MM. FLEXIBLE ADAPTOR | BZA | Substantially Equivalent | |
| K810620 | DISPOSABLE ELBOW ADAPTOR | BZA | Substantially Equivalent | |
| K801261 | DISPOSABLE COUPLING ADAPTOR | BYX | Substantially Equivalent | |
| K801260 | DISPOSABLE PRESSURE LINE ADAPTOR | BYX | Substantially Equivalent | |
| K800562 | DISPOSABLE HAND HELD NEBULIZER | CAF | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DYGCatheter, Flow Directed
- DQYCatheter, Percutaneous
- BZAConnector, Airway (Extension)
- EZNDilator, Catheter, Ureteral
- BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
- DYBIntroducer, Catheter
- CAFNebulizer (Direct Patient Interface)
- KRBProbe, Thermodilution
- NHKResuscitator, Manual, Non Self-Inflating
- BZOSet, Tubing And Support, Ventilator (W Harness)
- BYXTubing, Pressure And Accessories
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Intec Medical, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Intec Medical, Inc.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain