Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Arrow Intl., Inc. — Predicate Candidate Screening

110 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

86 daysmedian FDA review time
301 days90th percentile
110clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K100635ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTArrow Intl., Inc.2010-08-271750
K093050ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAArrow Intl., Inc.2009-12-18790
K071491ARROW INTERNATIONAL, INC., SURGICAL DRAPESArrow Intl., Inc.2007-10-101330
K071998ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENTArrow Intl., Inc.2007-09-26650
K071111NON-ABSORBABLE SILK SUTUREArrow Intl., Inc.2007-07-17880
K060309AUTOCAT INTRA-AORTIC BALLOON PUMP SERIESArrow Intl., Inc.2006-04-065829
K042126PICCArrow Intl., Inc.2004-08-27214
K041153SHARPSAWAY II LOCKING DISPOSABLE CUPArrow Intl., Inc.2004-07-12700
K040801INTRA-AORTIC BALLOON (IAB)Arrow Intl., Inc.2004-05-063813
K040802HEMOSONIC 200HEMODYNAMIC MONITORArrow Intl., Inc.2004-04-28300
K040100ARROW ECHOGENIC INTRODUCER NEEDLEArrow Intl., Inc.2004-03-01410
K031153MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MOArrow Intl., Inc.2003-11-252280
K032962AC 3 LUMEN CENTRAL VENOUS ACCESS KIT WITH ARROWG+ARD ANTIMICArrow Intl., Inc.2003-10-29360
K022662DIATEK CANNON-CATHETER, MODEL CC5500Arrow Intl., Inc.2003-05-092738
K021723SHEATH ADAPTER, MODEL SA-09847Arrow Intl., Inc.2002-08-08760
K021567STIMUCATH CONTINUOUS NERVE BLOCK SET, PRODUCT NUMBER AB-0500Arrow Intl., Inc.2002-06-19372
K021462ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTICArrow Intl., Inc.2002-06-063024
K021120RADIAL ARTERY CATHERIZATION SET WITH INTEGRAL NEEDLE PROTECTArrow Intl., Inc.2002-05-02241
K011761MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMIArrow Intl., Inc.2001-10-311474
K011056ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTDArrow Intl., Inc.2001-10-2420113
K002256ARROW ACAT 2 INTRA-AORTIC BALLOON PUMPArrow Intl., Inc.2001-05-032820
K002507TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIArrow Intl., Inc.2001-03-212186
K010330ARROW REDIGUARD, 9FR. 50CC, INTRA-AORTIC BALLOON VATHETER, IArrow Intl., Inc.2001-03-022813
K003006TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLArrow Intl., Inc.2000-10-27312
K99393314 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEArrow Intl., Inc.2000-09-143013
K00158719 GA PLASTIC REINFORCED EPIDURAL CATHETERArrow Intl., Inc.2000-07-12503
K000729ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CCArrow Intl., Inc.2000-05-197427
K993691ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOArrow Intl., Inc.2000-03-0812811
K9939668FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETERArrow Intl., Inc.2000-02-18871
K99143114 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KITArrow Intl., Inc.1999-05-26301
K984022PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KITArrow Intl., Inc.1999-05-181871
K990829ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD, MODArrow Intl., Inc.1999-05-04531
K982141ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER, MODEL # EM-56025Arrow Intl., Inc.1998-08-31750
K981782LOW PROFILE PORT ATTACHABLE CATHETER WITH BLUE FLEX TIP / 8FArrow Intl., Inc.1998-08-12840
K970689IAB-04840-U;IAB-04250-U;IAB-04240-U;IAB-04230-UArrow Intl., Inc.1998-06-044640
K970229ARROW TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SETArrow Intl., Inc.1998-02-133880
K965209ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1)Arrow Intl., Inc.1998-01-233921
K970864ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERSArrow Intl., Inc.1997-10-172214
K9638658 FR. -30CC NARROWFLEX SHEATHLESS INTRA-AORTIC BALLOON CATHEArrow Intl., Inc.1997-09-163570
K962577ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETERArrow Intl., Inc.1997-08-214161
K970080ARROW-TREROTOLA PTD CATHETERArrow Intl., Inc.1997-07-251970
K9639208 FR.-30CC NARROWFLEX INTRA-AORTIC BALLOON CATHETER,Arrow Intl., Inc.1997-06-172600
K963257PERIPHERALLY INSERTED MEDLINE CATHETERArrow Intl., Inc.1997-03-041970
K9631049.5 FR.- FLEXI-CATH INTRA-AORTIC AND CONTROL SYSTEMArrow Intl., Inc.1997-02-041790
K963684A2 PORT, DUAL LUMEN SYSTEM WITH DETACHED CATHETER, CATALOG #Arrow Intl., Inc.1996-10-24730
K960479ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETERArrow Intl., Inc.1996-10-172584
K961652LOW PROFILE PLASTIC PORT DETACHED CATHETER SYSTEM CATALOG #1Arrow Intl., Inc.1996-07-19800
K961615LOW PROFILE TITANIUM PORT DETACHED CATHETER SYSTEM CATALOG #Arrow Intl., Inc.1996-07-19840
K961583A PORT DETACHED CATHETER SYSTEM CATALOG #1002Arrow Intl., Inc.1996-07-18850
K961358ARROW SHEATHLESS INTRA-AORTIC BALLOON CATHETERArrow Intl., Inc.1996-07-02850

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda