Atlas FDA

ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903

FDA 510(k) clearance K940079 · decided 1994-11-30

Clearance details

K-number
K940079
Device name
ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903
Applicant
Arrow Intl., Inc.
Decision
Substantially Equivalent
Date received
1994-01-07
Decision date
1994-11-30
Days to decision
327 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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Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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Recalls involving this device

RecordFirmDate
Description/REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT: 9 FR/AK-0990 recall (Z-2385-2026)ARROW INTERNATIONAL, LLC2026-06-13
Percutaneous Sheath Introducer Kit with ARROWg+ard Blue Sheath, Integral Hemostasis Valve/ recall (Z-1160-2018)Arrow International Inc2018-03-05
Percutaneous Sheath Introducer Kit with ARROWg+ard Blue (R) Sheath, Integral Hemostasis Va recall (Z-0784-2010)Arrow International Inc2010-03-05
Arrow ARROWg+ard Super Arrow-Flex Percutaneous Sheath Introducers recall (Z-1492-2009)Arrow International Inc2009-06-24
9 French Super Arrow-Flex Percutaneous Sheath Introducer Kit with Arrowg and Blue Antimicr recall (Z-1035-03)Arrow International Inc2003-07-19