Atlas FDA

CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS

FDA 510(k) clearance K153487 · decided 2016-02-04

Clearance details

K-number
K153487
Device name
CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS
Applicant
Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
Decision
Substantially Equivalent
Date received
2015-12-04
Decision date
2016-02-04
Days to decision
62 days
Clearance type
Special
Product code
LJS
Device class
2
Regulation number
880.5970
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Reading, PA, US
Third-party review
No
Expedited review
No

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