Data / Medical devices / United States / HeartStitch, INC.
HeartStitch, INC.: FDA-registered device maker in Fountain Valley, CA, United States, 3 510(k) clearances
HeartStitch, INC. is registered with the FDA (registration 3009142291) in Fountain Valley, CA, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 19, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009142291
- Address
- 17074 Newhope St, Fountain Valley, CA, United States, 92708
- Owner or operator
- HeartStitch, Inc. (10036047)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- April 15, 2011
- Registered through
- 2026
- Brand names listed
- Cardio Inverter, HeartStitch EL, HeartStitch MR, HeartStitch TA, Inverter, KwiKnot, NobleStitch EL, NobleStitch MR and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clamp, Vascular | DXC | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Ligature Passing And Knot Tying | HCF | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 19, 2012 | K113494 | NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TA | GAW | Substantially Equivalent | Nobles Medical Technologies Ii, Inc. | accessdata.fda.gov |
| March 16, 2012 | K113763 | SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE | GAW | Substantially Equivalent | Nobles Medical Technologies Ii, Inc. | accessdata.fda.gov |
| July 24, 1998 | K980128 | BALADI INVERTER WITH COAXIAL AORTIC PUNCH | DXC | Substantially Equivalent | Cardio Medical Solutions, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Suture, Nonabsorbable, Synthetic, Polypropylene
- All makers of Clamp, Vascular
- All makers of Instrument, Ligature Passing And Knot Tying
Updated April 19, 2012. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.