ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM— 510(k) K072864

Name: FDA 510(k) clearance K072864
Creator: U.S. Food and Drug Administration
Published: 2008-03-13

Substantially Equivalent

St. Jude Medical, Cardiac Rhythm Management Divisi

FDA 510(k) clearance K072864 for ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM, Substantially Equivalent on 2008-03-13. Applicant: St. Jude Medical, Cardiac Rhythm Management Divisi. Device class: 2.

Clearance details

Applicant: St. Jude Medical, Cardiac Rhythm Management Divisi
Product code: Code DRB
Device class: Class 2
Regulation: 21 CFR 870.1380
Advisory panel: Cardiovascular
Date received: 2007-10-05
Decision date: 2008-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sylmar, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DRB

view all

K220280 — Arrow Stiffening Stylet2022-08-30
K191469 — Biotronik Stylets2019-08-01
K182660 — GaltTWS2019-05-30
K170298 — Liberator Beacon Tip Locking Stylet2017-10-18
K142116 — LLD EZ2014-08-12

More clearances from St. Jude Medical, Cardiac Rhythm Management Divisi

view all

K122090 — SJM CONFIRM IMPLANTABLE CARDIAC MONITOR2012-11-15
K120296 — CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETER2012-05-11
K120298 — CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE2012-05-08
K111943 — AGILLS PF DELIVERY SYSTEM2011-09-29
K103250 — CPS DIRECT SL II SLITTABLE OUTER CATHETER2011-01-19

Adverse events under product code DRB

product code DRB

Death: 36
Injury: 562
Total: 598

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.