Diag Corp.
United StatesFDA applicant, unverified
- Devices
- 9
What Diag Corp. makes
Diag Corp. manufactures disposable and permanent medical cables, pacing leads, and cardiovascular temperature sensing electrodes for cardiac devices. Their portfolio includes endocardial leads with tined or screw-in fixation, such as unipolar atrial leads and long-length pacing leads. They also produce transseptal sheath introducers and hemostasis adapters for procedural use.
The company’s devices are classified under FDA regulations as Class II and Class III, requiring premarket notification (510(k)) clearance. These products are listed in the FDA’s 510(k) database, reflecting their authorised status under US regulatory requirements. The manufacturer is based in the United States.
Catalogue
Disposable Patient Cable Ref K910645
Regimes: 510(k) Registry: 510(k)Permanent Endocard. Unipolar Tined Lead Ref K812905
Regimes: 510(k) Registry: 510(k)Cardiovascular Temp. Pacemaker Elec Ref K820003
Regimes: 510(k) Registry: 510(k)Endocard. Pacing Lead Long Length PL200 Ref K800349
Regimes: 510(k) Registry: 510(k)Perm. Endocardial Unipolar Tined Atrial Ref K812270
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Permanent & Temporary Pacemaker Electr. Ref K820262
Regimes: 510(k) Registry: 510(k)Daig Fast Cath(Tm) Transseptal Sheath Introducer Ref K911883
Regimes: 510(k) Registry: 510(k)Seal-Away Hemostasis Adapter, Model 406229 Ref K984062
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Diag Corp. have in the registry?
The registry currently lists 9 devices for Diag Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Diag Corp.'s devices?
Among its 9 most recently registered devices, Diag Corp. has devices listed in FDA 510(k) (9 devices).
What risk classes do Diag Corp.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Diag Corp.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Diag Corp. in the registry?
The most recently registered devices listed for Diag Corp. include DISPOSABLE PATIENT CABLE, PERMANENT ENDOCARD. UNIPOLAR TINED LEAD, CARDIOVASCULAR TEMP. PACEMAKER ELEC and ENDOCARD. PACING LEAD LONG LENGTH PL200.