HeartStitch, INC.

FDA Device Registration & Listing · Fountain Valley, CA, US · Registration 3009142291

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009142291
FEI Number
3009142291
Entity Name
HeartStitch, INC.
City/State/Country
Fountain Valley, CA, US
Establishment Address
17074 Newhope St, Fountain Valley, CA 92708, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device
Owner / Operator
HeartStitch, Inc. (Owner Number: 10036047)
Owner / Operator Contact Address
17074 Newhope Str., Fountain Valley, CA 92708, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Cardio Inverter Inverter HeartStitch EL NobleStitch TA HeartStitch MR HeartStitch TA NobleStitch EL NobleStitch MR SRM-Stitch¿ 8F KwiKnot

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2015-04-27
GAW Suture, Nonabsorbable, Synthetic, Polypropylene General, Plastic Surgery Class 2 878.5010 2012-06-07
GAW Suture, Nonabsorbable, Synthetic, Polypropylene General, Plastic Surgery Class 2 878.5010 2012-06-07
HCF Instrument, Ligature Passing And Knot Tying General, Plastic Surgery Class 1 878.4800 2011-04-15

Official Correspondent

Anthony Nobles

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HeartStitch, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
2031768 Nobles Medical Technologies II, Inc. Fountain Valley, CA, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009142291. Last updated year: 2026. Please use registration number 3009142291 when referencing this establishment in official correspondence.
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