Medical Device Manufacturer · US , Portsmouth , NH

Distronic Sterile Products, Inc. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1995

Recent clearances: WINGED & SUBCUTANEOUS INFUSION SETS, VENTED SOLUTION SET, EXTENSION SET WITH CHECK VALVE

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Distronic Sterile Products, Inc. General Hospital ✕

8 devices

1-8 of 8

Cleared Feb 21, 1996

WINGED & SUBCUTANEOUS INFUSION SETS

General Hospital · 65d

Cleared Feb 21, 1996

VENTED SOLUTION SET

General Hospital · 64d

Cleared Jan 23, 1996

EXTENSION SET WITH CHECK VALVE

General Hospital · 84d

Cleared Jan 23, 1996

MINIBORE STOPCOCK SET

General Hospital · 84d

Cleared Aug 07, 1995

SOLUTION ADMINISTRATION SET

General Hospital · 56d

Cleared Jul 26, 1995

CORE-RESISTANT HUBER INFUSION SET WITH Y-SITE

General Hospital · 167d

Cleared Jul 14, 1995

60 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENSION SET W/1.2...

General Hospital · 32d

Cleared Feb 08, 1995

INTRAVASCULAR ADMINISTRATION SET

General Hospital · 107d