Cirtec Medical

FDA Filings

This page includes the latest FDA filings for Cirtec Medical. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3009183442
• FEI Number: 3009183442
• Name: Cirtec Medical
• Owner & Operator: Cirtec Medical
• Contact Address: 9200 Xylon Ave N ; Brooklyn Park MN 55445 US
• Official Correspondent:
  • David Balcom
  • x-763-4938556-434
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 99 Print Shop Rd ; Enfield, CT 06082 US
• Establishment Type:
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Sterilize Medical Device for Another Party (Contract Sterilizer)

• Registration Number: 3004737415
• FEI Number: 3004737415
• Name: Cirtec Medical
• Owner & Operator: Cirtec Medical
• Contact Address: 9200 Xylon Ave N ; Brooklyn Park MN 55445 US
• Official Correspondent:
  • David Balcom
  • x-763-4938556-434
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 101 Cooper Court ; Los Gatos, CA 95032 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 3013368220
• FEI Number: 3013368220
• Name: CIRTEC MEDICAL
• Owner & Operator: Cirtec Medical
• Contact Address: 9200 Xylon Ave N ; Brooklyn Park MN 55445 US
• Official Correspondent:
  • David Balcom
  • x-763-4938556-434
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 9200 Xylon Avenue North ; Brooklyn Park, MN 55445 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K190422 | GEI Cirtec Medical	Viveve, Inc. 2.0 System	2019-10-18
PMN K183579 | GZF Cirtec Medical	Nalu Medical	2019-10-18
PMN K183579 | GZF CIRTEC MEDICAL	Nalu Medical	2019-10-18
PMN P080012 | LKK Cirtec Medical	Flowonix Medical	2017-10-13
LXH CIRTEC MEDICAL	Nevro	2017-03-08
PMN P130019 | PIM Cirtec Medical	Maestro	2015-02-02
PMN K140637 | KRA Cirtec Medical	PEREGRINE SYSTEM INFUSION CATHETER, CONTINUOUS FLUSH	2014-12-19
PMN K133016 | LRC Cirtec Medical	VENT-OS SINUS DILATION SYSTEM	2014-12-19
GZC Cirtec Medical	Nalu Medical	2012-12-05
PMN K122756 | JCX Cirtec Medical	Aspiration Pump	2012-11-12

Similar & Related FDA Registered Companies

• Cirtec Medical Corporation9200 Xylon Avenue Nbrooklyn Park, MN 55445 PMA NumberP170001 Date Received01/17/2017 Decision Date01/11/2023 Product Code EZW  Advisory Committee Gastroenterology/Urology Expedited Review Granted? No