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Nrg Transseptal Needle

by Baylis Medical Co., Inc.

510(k) K073326

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK073326 Date28 May 2008ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0393-2017 FDA Class II initiated 11 Oct 2016

    The firm is voluntarily recalling lots of the NRG Transseptal Needle and NRG RF Transseptal Kit due to the possibility for an integrity defect to the Tyvek pouch of the NRG Transseptal Needle.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DXF
Device Class
Class II
Regulation
21 CFR Part 870.5175
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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