Product code MCX ยท Class 3
Catheter, Coronary, Atherectomy
0510(k)s in 12 months (0 all time)
0recalls in 12 months (14 all time)
3recalls that name a 510(k)
Top companies in MCX
| Company | 510(k)s | Recalls |
|---|---|---|
| Boston Scientific Corporation | 0 | 8 |
| Cardiovascular Systems Inc | 0 | 4 |
| Possis Medical, Inc | 0 | 1 |
| St Jude Medical CRMD | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 8, 2022 | Boston Scientific Corporation ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support Open, Classified |
MCX | None listed |
| Mar 8, 2022 | Boston Scientific Corporation ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy Open, Classified |
MCX | None listed |
| Nov 8, 2021 | Boston Scientific Corporation Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU). Terminated |
MCX | None listed |
| Dec 19, 2019 | Boston Scientific Corporation AngioJet Ultra Consoles-Thrombectomy System
UPN:
105650-001D
105650-001H
105650-001R
105650-001Z
105650-002R
105650-004H
105650-004R
105650-007R
105650-009R
105650-024H
105650-024Z
105650-025
105650- Terminated |
MCX | None listed |
| Apr 13, 2018 | Cardiovascular Systems Inc CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.
Product Usage: Usage:
The pump is a component of the OAS that provides the pumping Terminated |
MCX | None listed |
| Apr 14, 2017 | Cardiovascular Systems Inc CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000. Terminated |
MCX | None listed |
| Jan 31, 2017 | Boston Scientific Corporation AngioJet Ultra 5000 A Console:Foot Switch
Material number (U PN) 105650
Cardiovascular: The Console is a multiple-use device that controls the Thrombectomy Set. It drives the pump, regulates fluid in Terminated |
MCX | None listed |
| Nov 13, 2015 | Boston Scientific Corporation RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Extra Support. REF H802233301 (5-pack outer package), REF H802233300 (single unit).
The Rotablator rotational at Terminated |
MCX | None listed |
| Nov 13, 2015 | Boston Scientific Corporation RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Floppy. REF H802223301 (5-pack outer package), REF H802223300 (single unit).
The Rotablator rotational atherecto Terminated |
MCX | None listed |
| Mar 20, 2015 | Cardiovascular Systems, Inc. Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125.
The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable can Terminated |
MCX | None listed |
| Feb 26, 2014 | Cardiovascular Systems, Inc. CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Number DBEC-125
Product Usage: The system is indicated to facilitate stent delivery in patients with coronary ar Terminated |
MCX | K071073 |
| Jun 21, 2007 | Possis Medical, Inc Angiojet Spiroflex, Catheter, 135 cm, 4F, Single use only, Sterilized with Ethylene Oxide, POSSIS MEDICAL, INC. 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003 USA-
(Spiroflex Rheolytic Thromb Terminated |
MCX | None listed |
| Jun 14, 2007 | St Jude Medical CRMD St. Jude Medical-CPS Direct SL- slittable CRT lead delivery tool. -Model Numbers 410110, 410111, 410112, 410113, 410114, 410115, 410116, 410120,410121. 410122, 410123, 410124, 410125 and 410126. Terminated |
MCX | K053277 |
| Jan 31, 2006 | Boston Scientific Corporation The Flextome Cutting Balloon Device consists of a balloon with 3 or 4 atherotomes (microsurgical blades)
mounted longitudinally on its outer surface. When the Flextome Cutting Balloon Device is inflat Terminated |
MCX | K052038 |
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