BD PRE-FILLED HEPARIN LOCK FLUSH IN 0.9% SODIUM CHLORIDE INJECTION, USP SYRINGE

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

BD

The following data is part of a premarket notification filed by Bd with the FDA for Bd Pre-filled Heparin Lock Flush In 0.9% Sodium Chloride Injection, Usp Syringe.

Pre-market Notification Details

• Device ID: K011967
• 510k Number: K011967
• Device Name: BD PRE-FILLED HEPARIN LOCK FLUSH IN 0.9% SODIUM CHLORIDE INJECTION, USP SYRINGE
• Classification: Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
• Applicant: BD 1 BECTON DR. MC 226 Franklin Lakes, NJ 07417
• Contact: Gregory W Morgan
• Correspondent: Gregory W Morgan; BD 1 BECTON DR. MC 226 Franklin Lakes, NJ 07417
• Product Code: FOZ
• CFR Regulation Number: 880.5200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-06-25
• Decision Date: 2002-01-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
50382903065313	K011967	000
50382903065108	K011967	000
50382903065115	K011967	000
50382903065122	K011967	000
50382903065139	K011967	000
50382903065146	K011967	000
50382903065153	K011967	000
50382903065160	K011967	000
50382903065177	K011967	000
50382903065214	K011967	000
50382903065252	K011967	000
50382903065276	K011967	000
50382903065283	K011967	000
50382903065092	K011967	000