HeartStitch, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30091422913009142291HeartStitch, INC.1N2026-01-0117074 Newhope St Fountain Valley CA US 92708

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
M705129007NobleStitch EL - The NobleStitch™ EL system deploys suture to close an open tissue site in the cardiovascular system, including Patent Foramen Ovale (PFO) closure.The NobleStitch™ EL system consists of two suture delivery devices (one identified as ‘S’, and one identified as ‘P’), and one accessory knot delivery device (identified as ‘KwiKnot™’). The devices work in harmony with each other to place sutures and a knot at the closure site. Also included with the system are other accessories that aid the user in the operation of the devices (accessories may vary).The NobleStitch™ EL suture delivery devices each utilize an arm that is preloaded with 4-0 non-absorbable polypropylene monofilament suture. The NobleStitch™ EL knot delivery ‘KwiKnot™’ device is preloaded with a non-absorbable polypropylene radiopaque knot. The devices do not require any suture or knot loading/manipulation prior to use.The NobleStitch™ EL system operates in the following manner: When a suture end is positioned by the NobleStitch™ EL S suture delivery device arm, a needle is deployed from the device; the deployed needle pierces the closure site tissue and engages the suture end located in the device arm. As the needle is then withdrawn from the arm it captures and retains the suture end. The retained suture end is drawn through the tissue and is retained at the tip of the retracted needle until removed by the user at the appropriate time. The opposite end of the same suture is then free to be removed from the device. The same process is then repeated for a second suture using the NobleStitch™ EL P suture delivery device. Both placed sutures (a total of four suture ends) are then threaded through the KwiKnot™ device. The KwiKnot™ device delivers and engages a two-piece knot to secure the suture at the closure site.+17144276348info@heartstitch.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1280531565948632K980128BALADI INVERTER WITH COAXIAL AORTIC PUNCHDXC1998-07-24
1280531136914086K113763SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIREGAW2012-03-16
1280532011126795K113494NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TAGAW2012-04-19
1280531437351207

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GAW22012-04-19
DXC11998-07-24

GUDID#