IBC CARDIAC SUCTION WARD
FDA 510(k) clearance K963756 · decided 1997-11-14
Clearance details
- K-number
- K963756
- Device name
- IBC CARDIAC SUCTION WARD
- Applicant
- International Biophysics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1996-09-17
- Decision date
- 1997-11-14
- Days to decision
- 423 days
- Clearance type
- Traditional
- Product code
- DTS
- Device class
- 2
- Regulation number
- 870.4420
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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| ROBICSEK INTRACARDIAC SUCTION WAND (K891906) | Gish Biomedical, Inc. | 1989-06-13 |
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| DISPOSSABLE SUCTION TUBE, 6 FRENCH (K791846) | Dlp, Inc. | 1979-10-02 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| IBC Suction Wand Catalog Number 1990S Product Usage: The IBC Suction Wand is a component o recall (Z-2422-2015) | International Biophysics Corp. | 2015-08-19 |
| IBC INTERNATIONAL BIOPHYSICS CORP. 2101-2 EAST ST. ELMO, SUITE 275, AUSTIN, TX 78744 SUCTI recall (Z-0273-2012) | International Biophysics Corp | 2011-11-23 |