Edwards Laboratories - FDA 510(k) Cleared Devices

Cleared Jul 28, 1980

MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR

K801552 · KRB

Cardiovascular · 20d

Cleared Apr 16, 1980

MODEL 100 SPECTRAVIEW

K800655 · DQC

Cardiovascular · 22d

Not Cleared Mar 17, 1980

CARPENTIER-EDWARDS FLEX. ANNULOPLASTY

K792441 · KRH

Cardiovascular · 109d

Cleared Dec 07, 1979

INTEGRAL DISPOSABLE HOLDER CARPENTIER

K792034 · DTJ

Cardiovascular · 58d

Cleared Feb 26, 1979

CARDIAC OUTPUT COMPUTER, MDEL 9520A

K790047 · DXG

Cardiovascular · 52d

Cleared Jan 15, 1979

DISPOSABLE HOLDER FOR BIOPROSTHESIS

K790022 · DTJ

Cardiovascular · 12d

Cleared Sep 15, 1978

AC ADAPTER:MODELS 9525,9526,9527

K781535 · DXG

Cardiovascular · 9d

Cleared Sep 20, 1977

PROBE & CATHETER

K771663 · KRB

Cardiovascular · 21d

Cleared Jun 22, 1977

VENA CAVA UMBRELLA FILTER, MODEL 7321

K771046 · DTK

Cardiovascular · 12d

Cleared Aug 26, 1976

APPLICATOR,ANGIOGRAPHY (7310MOBIN-UDDIN)

K760151 · DTK

Cardiovascular · 56d

Cleared Jul 19, 1976

FILTER (7220&7221 MOBIN-UDDIN VENA CAVA)

K760152 · DTK

Cardiovascular · 18d

Cleared Jul 19, 1976

COMPUTER, THERMODILUTION CARDIAC (9520)

K760192 · DXG

Cardiovascular · 13d