DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD.
FDA 510(k) clearance K905311 · decided 1991-01-15
Clearance details
- K-number
- K905311
- Device name
- DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD.
- Applicant
- Baxter Bentley Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-11-28
- Decision date
- 1991-01-15
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- DWD
- Device class
- 2
- Regulation number
- 870.4430
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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| SUCTION CONTROL VALVE (NONADJUSTABLE) CAT.RLV-2100 (K861428) | American Omni Medical, Inc. | 1986-06-26 |
| AJDJUSTABLE SUCTION CONTROL VALVE (K851406) | American Omni Medical, Inc. | 1985-08-05 |
| IL VIDEO 22,21 & II ATOMIC SPECTROPHOTO- (K830149) | Instrumentation Laboratory CO | 1983-02-28 |
Recalls involving this device
No recalls on record reference this clearance.