Atlas FDA

PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU

FDA 510(k) clearance K040569 · decided 2004-04-07

Clearance details

K-number
K040569
Device name
PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU
Applicant
Oscor, Inc.
Decision
Substantially Equivalent
Date received
2004-03-04
Decision date
2004-04-07
Days to decision
34 days
Clearance type
Special
Product code
DTB
Device class
3
Regulation number
870.3680
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Palm Harbor, FL, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
BIOTRONIK ENDOCARDIAL PACING LEADS (K061212)Biotronik, Inc.2006-07-10
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MODEL 4951M MYOCARDIAL UNIPOLAR LEAD (K031210)Metronic, Inc.2003-05-16
ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP (K023205)Biotronik, Inc.2003-04-24
PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB (K024053)Oscor, Inc.2003-01-31
MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS (K023803)Biotronik, Inc.2002-12-11
AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP (K023099)Biotronik, Inc.2002-10-18
AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP (K021217)Biotronik, Inc.2002-05-01
MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/15-BP; 45-JBP; 53-JBP (K010281)Biotronik, Inc.2002-04-09
PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB (K020669)Oscor, Inc.2002-03-28
PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS (K013339)Oscor, Inc.2001-11-08

Recalls involving this device

RecordFirmDate
Permanent Pacing Lead (Catalog #: 03332, 03334, 03337, 03107, 03116, 03108, 03109, 05756, recall (Z-2333-2008)Oscor, Inc.2008-09-24