FDA.reportPublic FDA data

510(k) K082199

Device
SPIRALFUSE PERIPHERAL INFUSION SYSTEM
Applicant
Bacchus Vascular, Inc.
510(k) number
K082199
Product code
QEY
Decision
Substantially Equivalent (SESE)
Decision date
2008-10-17
Date received
2008-08-04
Regulation
870.5150
Classification name
Mechanical Thrombolysis Catheter
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
BOB MCRAE
Address
3110 Coronado Dr. Santa Clara CA US 95054 95054

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QEY#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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K251318VariFuse Adjustable Infusion CatheterArgon Medical Devices, Inc.2026-01-20
K241851Versus™ Catheter (VS110-8B)Liquet Medical, Inc.2024-11-25
K231653BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular CatheterThrombolex, Inc.2023-07-03
K222095BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101Thrombolex, Inc.2023-04-20
K220866EKOS+ Endovascular DeviceBoston Scientific2022-04-20
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K211080EkoSonic Endovascular DeviceBoston Scientific2021-11-19
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K202347UNIFUSE Infusion System with Cooper WireAngioDynamics, Inc.2020-09-15
K200648EKOS PE Endovascular Device with Control System 4.0 (CS4.0)Ekos Corporation2020-08-17
K192864UNI*FUSE Infusion System with Cooper WireAngioDynamics, Inc.2020-06-01
K193071Bashir Plus Endovascular CatheterThrombolex, Inc.2019-12-17
K192598Bashir S-B Endovascular Catheter, Ref. No. 7101Thrombolex, Inc.2019-10-18
K191119EkoSonic Endovascular DeviceBtg International, Inc.2019-08-23