FDA 510(k) Applications for Medical Device Product Code "BTC"
(Bag, Reservoir)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K830056 | ARTEC ENVIRONMENTAL MONITORING DIVISION | ARTEC TWIST VALVE | 03/09/1983 |
| K791463 | CAMERON MEDICAL CORP. | "PARA-VENT" | 09/17/1979 |
| K800155 | DRYDEN CORP. | DISPOSAL LITER BREATHING BAG | 02/21/1980 |
| K821309 | ESP PLASTICS, INC. | ESPREE', BREATHING BAG | 05/21/1982 |
| K830399 | KHI, INC. | COUPLING/VALVE | 03/10/1983 |
| K880680 | KING SYSTEMS CORP. | KING SYSTEMS, BREATHING BAG | 03/03/1988 |
| K822116 | LIFE DESIGN SYSTEMS, INC. | ANESTHESIA BREATHING BAG, VARIOUS SIZES | 08/16/1982 |
| K932191 | LIFE SHIELD HEALTHCARE PRODUCTS, INC. | BREATHING BAGS | 07/02/1993 |
| K932581 | MED-PLASTICS INTL., INC. | BREATHING BAGS | 07/16/1993 |
| K894906 | MED-TEK CORP. | ANESTHESIA BREATHING BAGS "SIZES 1/2, 1,2,3 LITER" | 09/18/1989 |
| K791910 | MEM MEDICAL, INC. | THREE LITER BAG #M-512 | 10/09/1979 |
| K932584 | MERIT MEDICAL SYSTEMS, INC. | BREATHING BAGS | 07/16/1993 |
| K181424 | PeDIA, LLC | PeDIA | 09/25/2018 |
| K932496 | PRECISION MED PRODUCTS, LTD. | PRECISION MED PRODUCTS, LTD. BREATHING BAGS | 07/16/1993 |
| K822216 | QUEST MEDICAL, INC. | VOLUMETRIC CONTROLLER | 08/16/1982 |
| K864822 | SURGIDYNE, INC. | VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS | 01/15/1987 |
| K841411 | WARNE SURGICAL PRODUCTS, LTD. | ROLLED NECK W/PLUG | 04/18/1984 |
| K841412 | WARNE SURGICAL PRODUCTS, LTD. | ROLLED NECK W/TAP | 04/18/1984 |
| K940220 | ZEFON MEDICAL PRODUCTS | REBREATHER BAGS | 05/27/1994 |
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