Company ยท US
Intec Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 1991. Name variants (Inc, Corp, punctuation) are merged.
17510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DQY | Catheter, Percutaneous | 3 |
| BYX | Tubing, Pressure And Accessories | 2 |
| BZA | Connector, Airway (Extension) | 2 |
| DYB | Introducer, Catheter | 2 |
| DYG | Catheter, Flow Directed | 2 |
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | 1 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 1 |
| CAF | Nebulizer (Direct Patient Interface) | 1 |
| EZN | Dilator, Catheter, Ureteral | 1 |
| KRB | Probe, Thermodilution | 1 |
| NHK | Resuscitator, Manual, Non Self-Inflating | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 3, 1991 | K911840 | INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETER Intec Medical, Inc. | DYG |
| Oct 19, 1990 | K903217 | TAPERED TIP THE GUIDER CORONARY GUIDING CATHETER Intec Medical, Inc. | DQY |
| Oct 19, 1990 | K903216 | THE GUIDER CORONARY GUIDING CATHETER Intec Medical, Inc. | DQY |
| Oct 19, 1990 | K900710 | INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER Intec Medical, Inc. | KRB |
| Oct 16, 1990 | K903840 | GIANT LUMEN SAFETIP SERIES: ENDOMYOCARDIAL BIOPSY Intec Medical, Inc. | DYB |
| Sep 26, 1990 | K903906 | PERCUTANEOUS CATHETER INTRODUCER KIT Intec Medical, Inc. | DYB |
| Aug 14, 1990 | K900998 | INTERVENTIONAL MEDICAL Y ADAPTER W/ADJUST. VALVE Intec Medical, Inc. | DQY |
| Jul 31, 1990 | K901247 | TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES Intec Medical, Inc. | DYG |
| Dec 13, 1989 | K894925 | AMCATH URETERAL DILATORS MODELS 7100,7110,7120 Intec Medical, Inc. | EZN |
| Apr 2, 1986 | K860941 | DISPOSABLE HEATED WIRE LOOPS 48 AND 72 Intec Medical, Inc. | BZE |
| Dec 22, 1982 | K823271 | DISPOSABLE ADULT VO. VENTILATOR CIRCUIT Intec Medical, Inc. | BZO |
| Mar 12, 1982 | K813317 | DISP. HYPERINFLATION BAG SYSTEM Intec Medical, Inc. | NHK |
| Apr 17, 1981 | K810621 | DISPOSABLE 22MM. FLEXIBLE ADAPTOR Intec Medical, Inc. | BZA |
| Mar 20, 1981 | K810620 | DISPOSABLE ELBOW ADAPTOR Intec Medical, Inc. | BZA |
| Jun 9, 1980 | K801261 | DISPOSABLE COUPLING ADAPTOR Intec Medical, Inc. | BYX |
| Jun 4, 1980 | K801260 | DISPOSABLE PRESSURE LINE ADAPTOR Intec Medical, Inc. | BYX |
| Mar 25, 1980 | K800562 | DISPOSABLE HAND HELD NEBULIZER Intec Medical, Inc. | CAF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||