Contract manufacturerHeartStitch, INC. (Fountain Valley, CA)CaliforniaGeneral and plastic surgeryClass IIClass I
HeartStitch, INC.
Contract manufacturer · Fountain Valley, CA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3009142291 (openFDA record; or search FDA's registration database)
- FEI number
- 3009142291
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer; Contract manufacturer
- Owner or operator
- HeartStitch, Inc. (FDA owner/operator no. 10036047)
- Registered address
- 17074 Newhope St, Fountain Valley, CA 92708
- Contract listings
- 3 device listings, 2 product codes, first listed Apr 15, 2011
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | Class II | General and plastic surgery | Contract manufacturing | Jun 7, 2012 |
| HCF | Instrument, Ligature Passing And Knot Tying | Class I | General and plastic surgery | Contract manufacturing | Apr 15, 2011 |