Heartstitch Inc

FDA Filings

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

FDA Registration(s)

• Registration Number: 3009142291
• FEI Number: 3009142291
• Name: HeartStitch, INC.
• Owner & Operator: HeartStitch, Inc.
• Contact Address: 17074 Newhope Str. ; Fountain Valley CA 92708 US
• Official Correspondent:
  • Anthony Nobles
  • x-714-4276348-228
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 17074 Newhope St ; Fountain Valley, CA 92708 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 2031768
• FEI Number: 3002690289
• Name: Nobles Medical Technologies II, Inc.
• Owner & Operator: HeartStitch, Inc.
• Contact Address: 17074 Newhope Str. ; Fountain Valley CA 92708 US
• Official Correspondent:
  • Anthony Nobles
  • x-714-4276348-228
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 17072 Newhope St ; Fountain Valley, CA 92708 US
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
GUDID M705129007 Heartstitch, Inc.	NobleStitch EL	2023-06-02
PMN K980128 | DXC HeartStitch, INC.	Cardio Inverter	2015-04-27
PMN K113763 | GAW Nobles Medical Technologies II, Inc. [HeartStitch, Inc.]	SRM-Stitch? 8F	2012-06-07
PMN K113763 | GAW HeartStitch, INC.	SRM-Stitch? 8F	2012-06-07
PMN K113494 | GAW Nobles Medical Technologies II, Inc. [HeartStitch, Inc.]	NobleStitch TA	2012-06-07
PMN K113494 | GAW Nobles Medical Technologies II, Inc. [HeartStitch, Inc.]	NobleStitch MR	2012-06-07
PMN K113494 | GAW Nobles Medical Technologies II, Inc. [HeartStitch, Inc.]	NobleStitch EL	2012-06-07
PMN K113494 | GAW Nobles Medical Technologies II, Inc. [HeartStitch, Inc.]	HeartStitch TA	2012-06-07
PMN K113494 | GAW Nobles Medical Technologies II, Inc. [HeartStitch, Inc.]	HeartStitch MR	2012-06-07
PMN K113494 | GAW Nobles Medical Technologies II, Inc. [HeartStitch, Inc.]	HeartStitch EL	2012-06-07
PMN K113494 | GAW HeartStitch, INC.	NobleStitch TA	2012-06-07
PMN K113494 | GAW HeartStitch, INC.	NobleStitch MR	2012-06-07
PMN K113494 | GAW HeartStitch, INC.	NobleStitch EL	2012-06-07
PMN K113494 | GAW HeartStitch, INC.	HeartStitch TA	2012-06-07
PMN K113494 | GAW HeartStitch, INC.	HeartStitch MR	2012-06-07
PMN K113494 | GAW HeartStitch, INC.	HeartStitch EL	2012-06-07
HCF Nobles Medical Technologies II, Inc. [HeartStitch, Inc.]	KwiKnot	2011-04-15
HCF HeartStitch, INC.	KwiKnot	2011-04-15