PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH, BLUNT TIP,PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH 113

System, Applicator, Radionuclide, Remote-controlled

VARIAN MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Plastic Needle With Mandrin, 2.0 Mm Diameter, Length, Blunt Tip,plastic Needle With Mandrin, 2.0 Mm Diameter, Length 113.

Pre-market Notification Details

• Device ID: K141624
• 510k Number: K141624
• Device Name: PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH, BLUNT TIP,PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH 113
• Classification: System, Applicator, Radionuclide, Remote-controlled
• Applicant: VARIAN MEDICAL SYSTEMS, INC. 911 HANSEN WAY Palo Alto, CA 94304
• Contact: Peter J Coronado
• Correspondent: Peter J Coronado; VARIAN MEDICAL SYSTEMS, INC. 911 HANSEN WAY Palo Alto, CA 94304
• Product Code: JAQ
• CFR Regulation Number: 892.5700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-06-17
• Decision Date: 2015-03-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00816389025615	K141624	000
20810563021961	K141624	000
30810563021975	K141624	000
10810563021988	K141624	000
00810563021998	K141624	000
10810563022008	K141624	000
10810563022015	K141624	000
10810563022022	K141624	000
00816389022553	K141624	000
00816389022904	K141624	000
00816389024243	K141624	000
00816389024250	K141624	000
00816389024267	K141624	000
10816389027180	K141624	000