Atlas FDA

NEXIVA CLOSED IV CATHETER SYSTEM

FDA 510(k) clearance K032843 · decided 2004-02-27

Clearance details

K-number
K032843
Device name
NEXIVA CLOSED IV CATHETER SYSTEM
Applicant
Becton Dickinson Infusion Therapy Systems, Inc.
Decision
Substantially Equivalent
Date received
2003-09-11
Decision date
2004-02-27
Days to decision
169 days
Clearance type
Traditional
Product code
FOZ
Device class
2
Regulation number
880.5200
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Sandy, UT, 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
ClearSafe Closed System (K261041)MedSource Labs, LLC2026-07-10
MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV Catheter (K260539)MedSource Labs, LLC2026-07-09
Introcan Safety® Deep Access XL IV Catheter (K253235)B.Braun Medical, Inc.2026-05-15
BD Insyte™ IV Catheter (K252137)Becton Dickinson Infusion Therapy Systems, Inc.2026-04-02
Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm) (K252513)Poly Medicure Limited2026-04-01
SURFLO Hybria Closed System Safety IV Catheter (K252398)Terumo Medical Products (Hangzhou) Co., Ltd.2025-12-17
Polyshield Safety IV Catheters (K252677)Poly Medicure Limited2025-11-05
BD Saf-T-Intima™ Subcutaneous Catheter System (K251422)Becton Dickinson Infusion Therapy Systems, Inc.2025-10-08
BD Nexiva™ Closed IV Catheter System (K243403)Becton Dickinson Infusion Therapy Systems, Inc.2025-07-25
BD Cathena™ Safety IV Catheter (K251155)Becton Dickinson Infusion Therapy Systems, Inc.2025-07-11
BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter (K251654)Becton Dickinson Infusion Therapy Systems, Inc.2025-06-27
BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector (K250682)Becton Dickinson Infusion Therapy Systems, Inc.2025-06-03

Recalls involving this device

RecordFirmDate
BD Nexiva Closed IV Catheter System, REF 383530, 24GA 0.56IN, Becton Dickinson Infusion Th recall (Z-0829-2010)Becton Dickinson Medical Systems2010-02-02
BD Nexiva Closed IV Catheter System, REF 383531, 24GA 0.75IN, Becton Dickinson Infusion Th recall (Z-0830-2010)Becton Dickinson Medical Systems2010-02-02
BD Nexiva Closed IV Catheter System, REF 383532, 22GA 1.00IN, Becton Dickinson Infusion Th recall (Z-0831-2010)Becton Dickinson Medical Systems2010-02-02
BD Nexiva Closed IV Catheter System, REF 383533, 20GA 1.00IN, Becton Dickinson Infusion Th recall (Z-0832-2010)Becton Dickinson Medical Systems2010-02-02
BD Nexiva Closed IV Catheter System, REF 383534, 20GA 1.25IN, Becton Dickinson Infusion Th recall (Z-0833-2010)Becton Dickinson Medical Systems2010-02-02
BD Nexiva Closed IV Catheter System, REF 383536, 20GA 1.00IN, Becton Dickinson Infusion Th recall (Z-0834-2010)Becton Dickinson Medical Systems2010-02-02
BD Nexiva HF Closed IV Catheter System, REF 383537, 20GA 1.25IN, Becton Dickinson Infusion recall (Z-0835-2010)Becton Dickinson Medical Systems2010-02-02
BD Nexiva Closed IV Catheter System, REF 383538, 20GA 1.75IN, Becton Dickinson Infusion Th recall (Z-0836-2010)Becton Dickinson Medical Systems2010-02-02
BD Nexiva Closed IV Catheter System, REF 383539, 18GA 1.25IN, Becton Dickinson Infusion Th recall (Z-0837-2010)Becton Dickinson Medical Systems2010-02-02
BD Nexiva Closed IV Catheter System, REF 383540, 18GA 1.75IN, Becton Dickinson Infusion Th recall (Z-0838-2010)Becton Dickinson Medical Systems2010-02-02
BD Nexiva Closed IV Catheter System, REF 383647, 20GA 1.25IN, Becton Dickinson Infusion Th recall (Z-0839-2010)Becton Dickinson Medical Systems2010-02-02
BD Nexiva Closed IV Catheter System, REF 383649, 18GA 1.25IN, Becton Dickinson Infusion Th recall (Z-0840-2010)Becton Dickinson Medical Systems2010-02-02
BD Nexiva Closed IV Catheter System, 18 gauge recall (Z-0584-05)Becton Dickinson Infusion Therapy2005-03-10
BD Nexiva Closed IV Catheter System, 20 gauge recall (Z-0585-05)Becton Dickinson Infusion Therapy2005-03-10
BD Nexiva Closed IV Catheter System, 22 gauge recall (Z-0586-05)Becton Dickinson Infusion Therapy2005-03-10
BD Nexiva Closed IV Catheter System, 24 gauge recall (Z-0587-05)Becton Dickinson Infusion Therapy2005-03-10