Medical Device Manufacturer · US , Minnetonka , MN

Survivalink Corp. - FDA 510(k) Cleared Devices

7 submissions · 5 cleared · Since 1995

Recent clearances: FIRSTSAVE STAR BIPHASIC, MODEL 9210/9200, FIRSTSAVE BIPHASIC MODEL #9200 AND 9210, SURVIVALINK MULTIFUNCTIONAL ELECTRODE (SVL-9630)

View 7 510(k) Devices ↓

7

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Survivalink Corp. Cardiovascular ✕

7 devices

1-7 of 7

Cleared Feb 01, 2002

FIRSTSAVE STAR BIPHASIC, MODEL 9210/9200

Cardiovascular · 228d

Cleared Feb 22, 2001

FIRSTSAVE BIPHASIC MODEL #9200 AND 9210

Cardiovascular · 30d

Cleared Dec 10, 1999

SURVIVALINK MULTIFUNCTIONAL ELECTRODE (SVL-9630)

Cardiovascular · 87d

Cleared Jan 25, 1999

FIRSTSAVE BIPHASIC MODELS 9200 AND 9210

Cardiovascular · 210d

Cleared Jul 01, 1997

Cardiovascular · 141d

Cleared Jun 23, 1997

SVL-9130 DEFIBRILLATION ELECTRODE

Cardiovascular · 87d

Cleared Feb 09, 1995

VIVALINK AED DEFIBRILLATOR

Cardiovascular · 373d