Atlas FDA

TWIN-FUSOR/UNI-FUSOR BLOOD & FLUID INFUSION CUFF

FDA 510(k) clearance K893519 · decided 1989-08-15

Clearance details

K-number
K893519
Device name
TWIN-FUSOR/UNI-FUSOR BLOOD & FLUID INFUSION CUFF
Applicant
Statlabs, Inc.
Decision
Substantially Equivalent
Date received
1989-05-08
Decision date
1989-08-15
Days to decision
99 days
Clearance type
Traditional
Product code
KZB
Device class
1
Regulation number
866.2170
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Franklin, TN, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Statlabs

The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Recalls involving this device

RecordFirmDate
CASMED 500cc Unifusor Classic with piston gauge and thumbwheel valve. Model: 903TGA. It is recall (Z-0461-2009)CAS Medical Systems, Inc.2008-12-29
CASMED 500cc Unifusor with aneroid gauge and thumbwheel valve Model: 803FGA. It is designe recall (Z-0462-2009)CAS Medical Systems, Inc.2008-12-29
CASMED 500cc Unifusor with aneroid gauge and stopcock valve. Model: A803SGA . The letter A recall (Z-0463-2009)CAS Medical Systems, Inc.2008-12-29
Casmed 500cc Unifusor II with aneroid gauge and thumbwheel valve Model: 2803SGA. It is des recall (Z-0464-2009)CAS Medical Systems, Inc.2008-12-29
CASMED 500cc Unifusor with aneroid gauge and stopcock valve. Model: 803SGA. It is designed recall (Z-0465-2009)CAS Medical Systems, Inc.2008-12-29
CASMED 500cc Unifusor Classic with piston gauge and stopcock valve. Model : A903SGA. The l recall (Z-0466-2009)CAS Medical Systems, Inc.2008-12-29
CASMED 500cc Unifusor Classic with piston gauge and stopcock valve Model: 903SGA. It is de recall (Z-0467-2009)CAS Medical Systems, Inc.2008-12-29
CASMED 500cc Unifusor Classic with aneroid gauge and thumbwheel valve Model:FN-803FGA. Pri recall (Z-0468-2009)CAS Medical Systems, Inc.2008-12-29
CASMED 500cc Unifusor with a short tube. Private labeled for King Systems. Model: P500BAG. recall (Z-0469-2009)CAS Medical Systems, Inc.2008-12-29
CASMED 500cc Unifusor II with aneroid gauge and thumbwheel valve. Private labeled for Tran recall (Z-0470-2009)CAS Medical Systems, Inc.2008-12-29
CASMED 500cc Unifusor Classic with aneroid gauge and thumbwheel valve. Model: D803FGA. Pri recall (Z-0471-2009)CAS Medical Systems, Inc.2008-12-29