The following data is part of a premarket notification filed by Tz Medical, Inc. with the FDA for Padtac Electrophysiology Recording Catheters, Junction Cable Connector & Cable.
| Device ID | K021421 |
| 510k Number | K021421 |
| Device Name: | PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLE |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | TZ MEDICAL, INC. 7272 S.W. DURHAM RD., #800 Portland, OR 97224 |
| Contact | Madalyn Duncan |
| Correspondent | Madalyn Duncan TZ MEDICAL, INC. 7272 S.W. DURHAM RD., #800 Portland, OR 97224 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-03 |
| Decision Date | 2003-04-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811331017564 | K021421 | 000 |
| 00811331011852 | K021421 | 000 |