Atlas FDA

NAVIGATOR

FDA 510(k) clearance K853747 · decided 1986-01-08

Clearance details

K-number
K853747
Device name
NAVIGATOR
Applicant
Mainsfield Scientific, Inc.
Decision
Substantially Equivalent
Date received
1985-09-09
Decision date
1986-01-08
Days to decision
121 days
Clearance type
Traditional
Product code
DTB
Device class
3
Regulation number
870.3680
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Mansfield, MA, US
Third-party review
No
Expedited review
No

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RecordFirmDate
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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

Recalls involving this device

No recalls on record reference this clearance.