ESTECH CLEARVIEW MV ATRIAL DEPRESSOR
FDA 510(k) clearance K053021 · decided 2006-01-26
Clearance details
- K-number
- K053021
- Device name
- ESTECH CLEARVIEW MV ATRIAL DEPRESSOR
- Applicant
- Estech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-10-26
- Decision date
- 2006-01-26
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- DTS
- Device class
- 2
- Regulation number
- 870.4420
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Alameda, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS (K982891) | California Medical Laboratories, Inc. | 1998-09-30 |
| IBC CARDIAC SUCTION WARD (K963756) | International Biophysics Corp. | 1997-11-14 |
| FLEXIBLE INTRACARDIAC SUCTION DEVICE (K905008) | Gish Biomedical, Inc. | 1991-01-23 |
| HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLES (K900339) | Shiley, Inc. | 1990-03-28 |
| ROBICSEK INTRACARDIAC SUCTION WAND (K891906) | Gish Biomedical, Inc. | 1989-06-13 |
| OHIO DISPOSABLE CLEAR SUCTION INSTRUMENT (K801641) | Ohio Medical Products | 1980-07-28 |
| DISPOSABLE SUCKER SYSTEM (K801400) | Texas Medical Products, Inc. | 1980-06-30 |
| DISPOSSABLE SUCTION TUBE, 6 FRENCH (K791846) | Dlp, Inc. | 1979-10-02 |
Recalls involving this device
No recalls on record reference this clearance.