Atlas FDA

Versus™ Catheter (VS110-8B)

FDA 510(k) clearance K241851 · decided 2024-11-25

Clearance details

K-number
K241851
Device name
Versus™ Catheter (VS110-8B)
Applicant
Liquet Medical, Inc.
Decision
Substantially Equivalent
Date received
2024-06-27
Decision date
2024-11-25
Days to decision
151 days
Clearance type
Traditional
Product code
QEY
Device class
2
Regulation number
870.5150
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Glen Allen, VA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Versus™ Catheter (VS110-9NB) (K260149)Liquet Medical, Inc.2026-02-17
VariFuse Adjustable Infusion Catheter (K251318)Argon Medical Devices, Inc.2026-01-20
BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter (K231653)Thrombolex, Inc.2023-07-03
BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101 (K222095)Thrombolex, Inc.2023-04-20
EKOS+ Endovascular Device (K220866)Boston Scientific2022-04-20
EkoSonic Endovascular Device, EKOS+ Endovascular Device (K213422)Boston Scientific Corporation2021-12-14
EkoSonic Endovascular Device (K211080)Boston Scientific2021-11-19
BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref. 7210), BASHIR Plus 20 Endovascular Catheter (Ref. 7220), BASHIR Plus 30 Endovascular Catheter (Ref. 7230), BASHIR Plus 40 Endovascular Catheter (Ref. 7240) (K211061)Thrombolex, Inc.2021-06-10
UNIFUSE Infusion System with Cooper Wire (K202347)AngioDynamics, Inc.2020-09-15
EKOS PE Endovascular Device with Control System 4.0 (CS4.0) (K200648)Ekos Corporation2020-08-17
UNI*FUSE Infusion System with Cooper Wire (K192864)AngioDynamics, Inc.2020-06-01
Bashir Plus Endovascular Catheter (K193071)Thrombolex, Inc.2019-12-17

Recalls involving this device

No recalls on record reference this clearance.