510(k) K913896

JAIN BLOOD SHIELD by Jain Surgical Equipment, Inc. — Product Code JOL

K913896 is an FDA 510(k) premarket notification submitted by Jain Surgical Equipment, Inc. for the device "JAIN BLOOD SHIELD". The FDA issued a decision of Substantially Equivalent on March 6, 1992. The device falls under product code JOL (Catheter And Tip, Suction), a Class II device regulated under 21 CFR 880.6740. Jain Surgical Equipment, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 6, 1992
Date Received: August 30, 1991
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Catheter And Tip, Suction
Device Class: Class II
Regulation Number: 880.6740
Review Panel: HO
Submission Type

Other clearances for product code JOL

K051370 — STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F (August 12, 2005)
K000266 — PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION (July 12, 2001)
K000265 — PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION (July 12, 2001)
K003402 — WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FO (May 1, 2001)
K994321 — STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP (October 25, 2000)
K974758 — HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE (March 9, 1998)
K974759 — HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE (March 9, 1998)
K974397 — STERILE SALINE FOR CATHETER CARE (February 10, 1998)
K973734 — STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION (February 5, 1998)
K972372 — GERM TRAPPER SUCTION TUBE HOLDER (December 11, 1997)

510(k) K913896

Clearance Details

Device Classification

Other clearances by Jain Surgical Equipment, Inc.

Other clearances for product code JOL

FDA data resources