Company ยท US
International Biophysics Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1996 to 2021. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DTS | Sucker, Cardiotomy Return, Cardiopulmonary Bypass | 3 |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 3 |
| DPT | Probe, Blood-Flow, Extravascular | 2 |
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 2 |
| DWS | Instruments, Surgical, Cardiovascular | 2 |
| BYI | Percussor, Powered-Electric | 1 |
| CAW | Generator, Oxygen, Portable | 1 |
| DTY | Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass | 1 |
| DWD | Suction Control, Intracardiac, Cardiopulmonary Bypass | 1 |
| DWE | Tubing, Pump, Cardiopulmonary Bypass | 1 |
| GEX | Powered Laser Surgical Instrument | 1 |
| MJJ | Cpb Check Valve, Retrograde Flow, In-Line | 1 |
| MNJ | Valve, Pressure Relief, Cardiopulmonary Bypass | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 10, 2021 | K193663 | FloPump 57mL Centrifugal Pump International Biophysics Corporation | KFM |
| Dec 15, 2017 | K170029 | FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile International Biophysics Corporation | KFM |
| Mar 27, 2013 | K122480 | INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST International Biophysics Corporation | BYI |
| Jan 11, 2008 | K072688 | LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000 International Biophysics Corp. | CAW |
| Apr 17, 2003 | K030181 | INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEM International Biophysics Corp. | GEX |
| Feb 18, 2000 | K992657 | IBC VRV, MODEL 1350 International Biophysics Corp. | DWD |
| Jan 14, 2000 | K992785 | IBC FLOGUARD, MODEL 6050 International Biophysics Corp. | MJJ |
| Nov 19, 1999 | K992964 | IBC VENT VALVE, MODEL 1400 International Biophysics Corp. | MNJ |
| Mar 24, 1999 | K983272 | IBC FLOPUMP, MODEL 6000 International Biophysics Corp. | KFM |
| Apr 8, 1998 | K963703 | ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000) International Biophysics Corp. | DPT |
| Nov 14, 1997 | K963756 | IBC CARDIAC SUCTION WARD International Biophysics Corp. | DTS |
| Mar 20, 1997 | K963698 | CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4 International Biophysics Corp. | DTY |
| May 14, 1996 | K955380 | IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4) International Biophysics Corp. | DRY |
| May 14, 1996 | K955379 | IBC GAS CELL COMPONENTS (1/2, 3/8, 1/4) International Biophysics Corp. | DRY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 19, 2015 | International Biophysics Corp. 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 a Terminated |
DWS | None listed |
| Aug 19, 2015 | International Biophysics Corp. IBC Aortic Punch Catalog Numbers APM40, APL48A, APM44A, APL40A, APM40A, CVAPL36, CVAPL40, CVAPL44, CVAPL48, CVAPL52, APM28BM, APM36BM, APM40BM, APM44BM, APM48BM, APM40BK, APM48BK, APM36BK, APM44BK, AP Terminated |
DWS | None listed |
| Aug 19, 2015 | International Biophysics Corp. 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 Terminated |
DTS | K963756 |
| Nov 23, 2011 | International Biophysics Corp 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 h Terminated |
DTS | K963756 |
| Jul 12, 2006 | International Biophysics Corp IBC Suction Handle (Sterile), a component of Blood Recovery Suction Systems, part #1990S; International Biophysics Corp., Austin, TX. Terminated |
DWE | K841959 |
| Jul 12, 2006 | International Biophysics Corp 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 ex Terminated |
DPT | K963703 |