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FDA 510(k)

Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit

K-Number: K153226 · 2016-03-24

ApplicantZoll Circulation, Inc.
Decision Date2016-03-24
Product CodeNCX
Advisory CommitteeCV
DecisionUnknown

Device Summary

Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit is a medical device manufactured by Zoll Circulation, Inc.. It received FDA 510(k) clearance on 2016-03-24 under approval number K153226. The device is classified under product code NCX. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit?

Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit is a medical device that received FDA 510(k) clearance on 2016-03-24. It is manufactured by Zoll Circulation, Inc.. The 510(k) number is K153226.

When was Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit approved by the FDA?

Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit received FDA 510(k) clearance on 2016-03-24, under approval number K153226.

What company makes Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit?

Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit is manufactured by Zoll Circulation, Inc..

What is the FDA product code for Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit?

The FDA product code for Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit is NCX.

Related Clinical Trials

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Other Devices by Zoll Circulation, Inc.

K213031Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console K220008Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console K231182Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System K221700AutoPulse NXT Resuscitation System K223746Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ Console K250979Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad)

View all 8 devices →

Related Devices (Code: NCX)

K152946TEMPEDYSeiratherm GmbH K153162HypocoreNovocor Medical Systems, Inc. K213031Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP ConsoleZoll Circulation, Inc. K220008Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ ConsoleZoll Circulation, Inc. K223746Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ ConsoleZoll Circulation, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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