Atlas FDA

ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER

FDA 510(k) clearance K122854 · decided 2013-01-04

Clearance details

K-number
K122854
Device name
ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER
Applicant
Arrow International (Subsidiary of Teleflex Inc.)
Decision
Substantially Equivalent
Date received
2012-09-18
Decision date
2013-01-04
Days to decision
108 days
Clearance type
Traditional
Product code
DYB
Device class
2
Regulation number
870.1340
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Reading, PA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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

RecordFirmDate
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FieldFlex Steerable Sheath (K261492)CenterPoint Systems, LLC2026-06-05
Echo Large Bore Introducer Sheath (K260606)Echo Medical, LLC2026-04-29
Introducer Sheath Set (K254248)Cardiocycle Medical(Suzhou) Co., Ltd.2026-04-23
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Recalls involving this device

RecordFirmDate
Arrow Glide Thru Peel-Away Sheath/Dilator Introducer recall (Z-2699-2017)Arrow International Inc2017-06-27
ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ARROW Advantag recall (Z-0207-2016)Arrow International Inc2015-11-04