Decision Date2016-03-24
Product CodeNCX
Advisory CommitteeCV
DecisionUnknown
Device Summary
Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit is the device name listed in this FDA 510(k) record. The listed applicant is Zoll Circulation, Inc.. It received FDA 510(k) clearance on 2016-03-24 under 510(k) 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. The listed applicant is Zoll Circulation, Inc.. The 510(k) number is K153226.
When did Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit receive FDA 510(k) clearance?
Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit received FDA 510(k) clearance on 2016-03-24, under 510(k) number K153226.
Who is the listed applicant for Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit?
The FDA 510(k) record lists Zoll Circulation, Inc. as the applicant. This does not by itself establish the device manufacturer.
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.
Other records listing Zoll Circulation, Inc. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
PMA P170027System, oxygen, aqueousK250979Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad)K231182Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management SystemK221700AutoPulse NXT Resuscitation SystemK223746Solex 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 ConsoleK220008Solex 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 View all 8 devices →
Related Devices (Code: NCX)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.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.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.K152946TEMPEDYSeiratherm GmbHK153162HypocoreNovocor Medical Systems, 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.