Atlas FDA

ARROW RADIAL ARTERY CATHETERIZATION SET

FDA 510(k) clearance K810675 · decided 1981-03-27

Clearance details

K-number
K810675
Device name
ARROW RADIAL ARTERY CATHETERIZATION SET
Applicant
Arrow Intl., Inc.
Decision
Substantially Equivalent
Date received
1981-03-12
Decision date
1981-03-27
Days to decision
15 days
Clearance type
Traditional
Product code
DQX
Device class
2
Regulation number
870.1330
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Description/REF: RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A; RA CATH KIT: 20 GA X 1-1/2IN/NA recall (Z-2397-2026)ARROW INTERNATIONAL, LLC2026-06-13
Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Sprin recall (Z-3299-2024)ARROW INTERNATIONAL Inc.2024-09-26
Arterial Line Catheterization Kit with Sharps Safety Features Permits access to the periph recall (Z-2740-2016)Arrow International Inc2016-09-07
Radial Artery Catheterization Kit with Sharps Safety Features Permits access to the periph recall (Z-2741-2016)Arrow International Inc2016-09-07
Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product recall (Z-2201-2016)Arrow International Inc2016-07-12
Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product recall (Z-2202-2016)Arrow International Inc2016-07-12
Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflu recall (Z-0066-2015)Arrow International Inc2014-10-14
ARTERIAL LINE KIT/Product SKU (Code) AK-04510 Arterial line kit recall (Z-1346-2011)Arrow International Inc2011-02-17
ARTERIAL CATHETERIZATION KIT/Product SKU (Code) ASK-04100-AMC. Arterial catheterization ki recall (Z-1355-2011)Arrow International Inc2011-02-17
RADIAL ARTERY CATHETERIZATION KIT/Product SKU (Code) ASK-04120-VBH. Cardiovascular artery recall (Z-1356-2011)Arrow International Inc2011-02-17
QuickFlash(R) RADIAL ARTERY/ARTERIAL LINE CATHETERIZATION KIT/Product SKU (Code) ASK-04500 recall (Z-1357-2011)Arrow International Inc2011-02-17
ARTERIAL CATHETERIZATION KIT/Product SKU's (Codes) CC-04100, FS-04510, NS-04100 and PW-041 recall (Z-1358-2011)Arrow International Inc2011-02-17
RADIAL ARTERY CATHETERIZATION KIT with SHARPS SAFETY FEATURES/Product SKU (Code) HF-04020- recall (Z-1359-2011)Arrow International Inc2011-02-17
ARTERIAL ACCESS TRAY/Product SKU (Code) MMC-04001-1. Arterial access tray for radial arter recall (Z-1360-2011)Arrow International Inc2011-02-17
Arterial Catheterization Set recall (Z-2494-2010)Arrow International Inc2010-09-25
Femoral Artery Catheterization Set recall (Z-2495-2010)Arrow International Inc2010-09-25