Atlas FDA

SONICATH ULTRA IMAGING CATHETER 3.2F 20MHZ, MODELS 37410/456221/C1020

FDA 510(k) clearance K041818 · decided 2004-11-10

Clearance details

K-number
K041818
Device name
SONICATH ULTRA IMAGING CATHETER 3.2F 20MHZ, MODELS 37410/456221/C1020
Applicant
Boston Scientific Corp
Decision
Substantially Equivalent
Date received
2004-07-06
Decision date
2004-11-10
Days to decision
127 days
Clearance type
Special
Product code
ITX
Device class
2
Regulation number
892.1570
Medical specialty
Radiology
Advisory committee
Radiology
Location
Fremont, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

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