510(k) K992657
- Device
- IBC VRV, MODEL 1350
- Applicant
- INTERNATIONAL BIOPHYSICS CORP.
- 510(k) number
- K992657
- Product code
- DWD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-02-18
- Date received
- 1999-08-09
- Regulation
- 870.4430
- Classification name
- Suction Control, Intracardiac, Cardiopulmonary Bypass
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- H. DAVID SHOCKLEY, JR.
- Address
- 4020 S. Industrial Dr. Suite 160 Austin TX US 78744 78744
FDA Registration Numbers#
- 1928237
- 3008500478
- 1319639
- 3022320321
- 3031571797
- 3012494290
- 1649914
- 1423507
Source Documents#
Other 510(k) Records For Product Code DWD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K920077 | NIKKISO NK PUMP | International Medical Products, Inc. | 1993-09-29 |
| K915480 | B-D ULTRA-VUE PROCEDURE NEEDLE W/ SPINAL TYPE PT. | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-01-07 |
| K915481 | B-D ULTRA-VUE PROCEDURE NEEDLE W/ CHIBA TYPE POINT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-01-07 |
| K915482 | B-D ULTRA-VUE PROCEDURE NEEDLE W/ WESTCOTT TYPE PT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-01-07 |
| K905311 | DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD. | Baxter Bentley Laboratories, Inc. | 1991-01-15 |
| K895427 | MEDISEAL SUCTION CANISTER | Deroyal Industries, Inc. | 1990-01-19 |
| K864503 | MODIFIED RLV-2100 B | American Omni Medical, Inc. | 1987-01-06 |
| K863593 | SARNS SAFETY LOOP | 3M Health Care, Sarns | 1986-11-18 |
| K862540 | LEFT VENTRICULAR VENT VALVE MODEL NO. GLV | Gish Biomedical, Inc. | 1986-08-29 |
| K861428 | SUCTION CONTROL VALVE (NONADJUSTABLE) CAT.RLV-2100 | American Omni Medical, Inc. | 1986-06-26 |
| K851406 | AJDJUSTABLE SUCTION CONTROL VALVE | American Omni Medical, Inc. | 1985-08-05 |
| K830149 | IL VIDEO 22,21 & II ATOMIC SPECTROPHOTO- | Instrumentation Laboratory CO | 1983-02-28 |
| K830150 | VEINPREP VEIN GRAFT PREP. KIT A277723 | Atrium Medical Corp. | 1983-02-28 |
| K760894 | VACUUM RELIEF VALVE | Delta Medical Industries | 1976-12-09 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases