Spatz Fgia, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000012214
- Devices
- 1
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA establishment
What Spatz Fgia, Inc. makes
Spatz Fgia, Inc. manufactures the Spatz3 Adjustable Balloon System, a medical device designed for vascular interventions requiring precise balloon dilation within coronary or peripheral arteries. The system is intended to provide controlled expansion to treat stenosis or other arterial blockages, with adjustable features to accommodate varying clinical needs.
The Spatz3 Adjustable Balloon System is classified as a Class III device under FDA regulations and is authorised through a Premarket Approval (PMA) application. The company is headquartered in the United States, and the device is listed in the FDA’s PMA registry.
Catalogue
Spatz3 Adjustable Balloon System Ref P190012
Regimes: CE MDD PMA Registry: EUDAMEDPMA
Company details
- EUDAMED SRN
- US-MF-000012214
- EU VAT number
- 203397381
- EUDAMED status
- Active
- EUDAMED registered name
- Spatz FGIA Inc.
- Registered address
- 1801 S Perimeter Road STE 130, 33309, Fort Lauderdale, United States
- Website
- www.spatzmedical.com
- [email protected]
- PRRC contact
- Pnina Polishuk
FDA establishments
- Spatz Fgia Inc. Ra'anana Central · IL FEI 3015409025
Frequently asked questions
How many devices does Spatz Fgia, Inc. have in the registry?
The registry currently lists 1 device for Spatz Fgia, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Spatz Fgia, Inc.'s devices?
Among its 1 most recently registered device, Spatz Fgia, Inc. has devices listed in EUDAMED (1 device) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Spatz Fgia, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Spatz Fgia, Inc.'s devices are Class III. Each device page shows its own class and authorisation.
What are the newest devices from Spatz Fgia, Inc. in the registry?
The most recently registered devices listed for Spatz Fgia, Inc. include Spatz3 Adjustable Balloon System.
Which FDA establishments are linked to Spatz Fgia, Inc.?
1 FDA establishment is linked to Spatz Fgia, Inc. in the registry; they are listed on the company page.