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SoundBite Console, SoundBite Active Wire 18

by Soundbite Medical Solution, Inc.

510(k) K192211

SoundBite Console, SoundBite Active Wire 18 is a medical device (FDA Class II; FDA product code PDU, Catheter For Crossing Total Occlusions) made by Soundbite Medical Solution, Inc., cleared under FDA 510(k) K192211 on 17 Jan 2020, active as of 10 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 10 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 10 Oct 2026.

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK192211 Date17 Jan 2020ClearedStatusActive

Official records

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  • Withdrawn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
PDU
Device class
Class II
Regulation
21 CFR Part 870.1250
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Similar devices

Other devices filed under FDA product code PDU (Catheter For Crossing Total Occlusions).