Atlas FDA

PLACEMENT-PLUS

FDA 510(k) clearance K003642 · decided 2000-12-20

Clearance details

K-number
K003642
Device name
PLACEMENT-PLUS
Applicant
Catheter Innovations, Inc.
Decision
Substantially Equivalent
Date received
2000-11-27
Decision date
2000-12-20
Days to decision
23 days
Clearance type
Special
Product code
LJS
Device class
2
Regulation number
880.5970
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Salt Lake City, UT, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.