International Biophysics Corp.
Austin, TX, US
International Biophysics Corp. appears in FDA device records in Austin, TX. FDA records list 14 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 6 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 14 510(k) clearances for International Biophysics Corp. between 1996 and 2021. The busiest year on record is 1996, with 2. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 2 |
| 1997 | 2 |
| 1998 | 1 |
| 1999 | 2 |
| 2000 | 2 |
| 2003 | 1 |
| 2008 | 1 |
| 2013 | 1 |
| 2017 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K193663 | FloPump 57mL Centrifugal Pump | KFM | Substantially Equivalent | |
| K170029 | FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile | KFM | Substantially Equivalent | |
| K122480 | INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST | BYI | Substantially Equivalent | |
| K072688 | LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000 | CAW | Substantially Equivalent | |
| K030181 | INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEM | GEX | Substantially Equivalent | |
| K992657 | IBC VRV, MODEL 1350 | DWD | Substantially Equivalent | |
| K992785 | IBC FLOGUARD, MODEL 6050 | MJJ | Substantially Equivalent | |
| K992964 | IBC VENT VALVE, MODEL 1400 | MNJ | Substantially Equivalent | |
| K983272 | IBC FLOPUMP, MODEL 6000 | KFM | Substantially Equivalent | |
| K963703 | ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000) | DPT | Substantially Equivalent | |
| K963756 | IBC CARDIAC SUCTION WARD | DTS | Substantially Equivalent | |
| K963698 | CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4 | DTY | Substantially Equivalent | |
| K955380 | IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4) | DRY | Substantially Equivalent | |
| K955379 | IBC GAS CELL COMPONENTS (1/2, 3/8, 1/4) | DRY | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- MJJCpb Check Valve, Retrograde Flow, In-Line
- CAWGenerator, Oxygen, Portable
- DRYMonitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
- BYIPercussor, Powered-Electric
- GEXPowered Laser Surgical Instrument
- DPTProbe, Blood-Flow, Extravascular
- KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type
- DTYSensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
- DTSSucker, Cardiotomy Return, Cardiopulmonary Bypass
- DWDSuction Control, Intracardiac, Cardiopulmonary Bypass
- MNJValve, Pressure Relief, Cardiopulmonary Bypass
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2424-2015 | IBC Vascular Loop Catalog Number CH111, CH112, CH113, CH114, CH115, CH116, CH118 Product Usage: The IBC Vascular Loop is a single-use, disposable loop used in occluding, retracting, and identifying arteries, veins, tendons, and nerves in surgical procedures. | It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria. | Class II | Terminated | |
| Z-2423-2015 | IBC Aortic Punch Catalog Numbers APM40, APL48A, APM44A, APL40A, APM40A, CVAPL36, CVAPL40, CVAPL44, CVAPL48, CVAPL52, APM28BM, APM36BM, APM40BM, APM44BM, APM48BM, APM40BK, APM48BK, APM36BK, APM44BK, APM28, APM36, APL44, APM40 Product Usage: The IBC Aortic Punch is a single-use, disposable surgical punch used to create an opening in the wall of the aorta to prepare a site for anastomosis. | It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria. | Class II | Terminated | |
| Z-2422-2015 | IBC Suction Wand Catalog Number 1990S Product Usage: The IBC Suction Wand is a component of Blood Recovery System for use in open heart procedures, autologous blood recovery and blood suction. It is a disposable, single use component. | It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria. | Class II | Terminated | |
| Z-0273-2012 | IBC INTERNATIONAL BIOPHYSICS CORP. 2101-2 EAST ST. ELMO, SUITE 275, AUSTIN, TX 78744 SUCTION HANDLE (STERILE) PART NUMBER: 1990S LOT NUMBER 041811-2065 EXPIRATION DATE: 18/APR/2015 For use in open heart procedures, Autologus blood recovery or blood suction. Product is a component of Blood Recovery Systems. | Potential for the sterility to be compromised. | Terminated | ||
| Z-1222-06 | IBC Suction Handle (Sterile), a component of Blood Recovery Suction Systems, part #1990S; International Biophysics Corp., Austin, TX. | Tyvek pouches containing device labeled as sterile have defective seals. | Terminated | ||
| Z-1223-06 | IBC FloProbe (Non-sterile), a disposable flow probe that is used as a component of the Medtronic Bio-Console System. The Medtronic Bio-Console System is intended for use in the monitoring of the extracorporeal cardiopulmonary bypass circuit blood flow rate during open heart surgery. part #3080N; packaged 10 per carton; International Biophysics Corp., Austin, TX. | Complaints received regarding the device's failure to zero out. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain