CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003, DS2C004, DS2C005

Catheter, Percutaneous

ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI

The following data is part of a premarket notification filed by St. Jude Medical, Cardiac Rhythm Management Divisi with the FDA for Cps Direct Sl Ii Slittable Outer Catheter, Models Ds2c001, Ds2c002, Ds2c003, Ds2c004, Ds2c005.

Pre-market Notification Details

• Device ID: K092075
• 510k Number: K092075
• Device Name: CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003, DS2C004, DS2C005
• Classification: Catheter, Percutaneous
• Applicant: ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 15900 VALLEY VIEW CT. Sylmar, CA 91342
• Contact: Colleen Canan
• Correspondent: Colleen Canan; ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 15900 VALLEY VIEW CT. Sylmar, CA 91342
• Product Code: DQY
• CFR Regulation Number: 870.1250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-07-09
• Decision Date: 2009-08-07

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05414734218337	K092075	000
05414734218191	K092075	000
05414734218207	K092075	000
05414734218214	K092075	000
05414734218221	K092075	000
05414734218238	K092075	000
05414734218245	K092075	000
05414734218252	K092075	000
05414734218269	K092075	000
05414734218276	K092075	000
05414734218283	K092075	000
05414734218290	K092075	000
05414734218313	K092075	000
05414734218320	K092075	000
05414734218009	K092075	000