510(k) K932370

REMINGTON MEDICAL DISPOS TEAR-AWAY VASC INTRO SET by Remington Medical, Inc. — Product Code DYB

K932370 is an FDA 510(k) premarket notification submitted by Remington Medical, Inc. for the device "REMINGTON MEDICAL DISPOS TEAR-AWAY VASC INTRO SET". The FDA issued a decision of Substantially Equivalent on November 9, 1993. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Remington Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 1993
Date Received
May 14, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type