DTF — Tools, Pacemaker Service Class I

FDA Device Classification

FDA product code DTF covers "Tools, Pacemaker Service", a Class I medical device regulated under 21 CFR 870.3730. Submissions are reviewed by the Cardiovascular panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
DTF
Device Class
Class I
Regulation Number
870.3730
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K875147cardiac pacemakersTORQUE HEX WRENCHJanuary 27, 1988
K781179telectronicsWRENCH, GEXAGON, DRIVERJuly 27, 1978