Decision Date2016-09-15
Product CodeNCX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
TEMPEDY is the device name listed in this FDA 510(k) record. The listed applicant is Seiratherm GmbH. It received FDA 510(k) clearance on 2016-09-15 under 510(k) number K152946. The device is classified under product code NCX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TEMPEDY?
TEMPEDY is a medical device that received FDA 510(k) clearance on 2016-09-15. The listed applicant is Seiratherm GmbH. The 510(k) number is K152946.
When did TEMPEDY receive FDA 510(k) clearance?
TEMPEDY received FDA 510(k) clearance on 2016-09-15, under 510(k) number K152946.
Who is the listed applicant for TEMPEDY?
The FDA 510(k) record lists Seiratherm GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TEMPEDY?
The FDA product code for TEMPEDY is NCX.
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.K153162HypocoreNovocor Medical Systems, Inc.K153226Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up KitZoll 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.