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Lariat RS

by Sentreheart, Inc

Lariat RS is a Class I device made by Sentreheart, Inc, cleared under FDA 510(k) K153096 on 25 Nov 2015 and listed in FDA GUDID since 14 Oct 2016 (UDI-DI M95530060), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K153096

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberM95530060 UDI-DI Date14 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK153096 Date25 Nov 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K153096 decided 25 Nov 2015 Active
  • FDA GUDID UDI-DI M95530060 listed 14 Oct 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K153096
  2. Listed FDA GUDID M95530060

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Lariat
Generic name
Open-surgery ligature loop
Model / reference
RS
Primary DI / UDI-DI
M95530060
510(k) Number
FDA product code
HCF, GAT
GMDN term
Open-surgery ligature loop
Device class
Class I
Regulation number
878.4800, 878.5000
GUDID distribution status
In Commercial Distribution

Related devices

Category: Open-surgery ligature loop

Cleared under the same submission (K153096)

Similar devices

Other devices filed under FDA product code HCF (Instrument, Ligature Passing And Knot Tying).

Other devices from Sentreheart, Inc

See all devices from Sentreheart, Inc →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)