Atlas FDA

ENDOWAVE INFUSION SYSTEM

FDA 510(k) clearance K072507 · decided 2007-10-04

Clearance details

K-number
K072507
Device name
ENDOWAVE INFUSION SYSTEM
Applicant
Ekos Corp.
Decision
Substantially Equivalent
Date received
2007-09-06
Decision date
2007-10-04
Days to decision
28 days
Clearance type
Special
Product code
QEY
Device class
2
Regulation number
870.5150
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Bothell, WA, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

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Recalls involving this device

RecordFirmDate
EKOS EndoWave Infusion System consisting of a Drug Delivery Catheter and an Ultrasound Cor recall (Z-1892-2008)EKOS Corporation2008-09-16
PT-3B Control Unit - component of the EndoWave Infusion Catheter System. EndoWave Infusion recall (Z-1752-2008)EKOS Corporation2008-09-02
Infusion System. EKOS EndoWave Infusion System. EKOS EndoWave Infusion System Drug Deliver recall (Z-1773-2008)EKOS Corporation2008-08-20