Atlas FDA

PERCUTANEOUS SHEATH INTRODUCER KIT

FDA 510(k) clearance K780532 · decided 1978-04-21

Clearance details

K-number
K780532
Device name
PERCUTANEOUS SHEATH INTRODUCER KIT
Applicant
Arrow Intl., Inc.
Decision
Substantially Equivalent
Date received
1978-04-04
Decision date
1978-04-21
Days to decision
17 days
Clearance type
Traditional
Product code
DYB
Device class
2
Regulation number
870.1340
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Mchenry, IL, 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
NAMIC Dilator and Sheath (K253526)Medline Industries, LP2026-07-29
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SimplGuide (K261242)Pendracare2026-06-25
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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
Edwards eSheath+ introducer set (K254279)Edwards Lifesciences2026-04-17
Aventus Introducer Sheath (K260091)Inquis Medical2026-04-13
Protaryx Transseptal Puncture Device (PTX2-001) (K260839)Protaryx Medical, Inc.2026-04-10
AuST Steerable Sheath (K260942)CenterPoint Systems, LLC2026-04-07
VANES Delivery System (VDS) (K260459)Zoll Respicardia, Inc.2026-04-06

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 Integral Hemostasis Valve/Side Port, Sharps Safety recall (Z-1158-2018)Arrow International Inc2018-03-05
Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflu recall (Z-0066-2015)Arrow International Inc2014-10-14
Arrow Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products perm recall (Z-1713-2014)Arrow International Inc2014-06-04
Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used recall (Z-0468-2014)Arrow International Inc2013-12-09
Super Arrow-Flex(R) PSI Set Intended for use in the hospital catheterization laboratory fo recall (Z-0936-2011)Arrow International Inc2011-01-21