The following data is part of a premarket notification filed by St. Jude Medical, Cardiac Rhythm Management Divisi with the FDA for Psa Cable, Models 4160 And 4161 And Psa Cable Adapter, Model 4053a.
| Device ID | K093858 |
| 510k Number | K093858 |
| Device Name: | PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A |
| Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
| Applicant | ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 15900 VALLEY VIEW CT. Sylmar, CA 91342 |
| Contact | Beena Flynn |
| Correspondent | Beena Flynn ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 15900 VALLEY VIEW CT. Sylmar, CA 91342 |
| Product Code | DSA |
| CFR Regulation Number | 870.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-16 |
| Decision Date | 2010-04-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15414734509746 | K093858 | 000 |
| 05414734503181 | K093858 | 000 |