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B-D Durasafe)Tm) Variable Extension Combined Spinal Epidural *cse) Needle Set/Kit

by Bd Becton Dickinson Vacutainer Systems Preanalytic 510(k)

Active United States

510(k) K945497

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESK Substantially Equivalent — Kit · Traditional NumberK945497 Date13 Feb 1995ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
CAZ
Device Class
Class II
Regulation
21 CFR Part 868.5140
Advisory Committee
Anesthesiology
FDA Decision
SESK Substantially Equivalent — Kit

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