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FDA 510(k)

CAPIJECT SYS CAPILLARY BLOOD COLLECT

K-Number: K833475 · 1983-12-08

ApplicantTerumo Medical Corp.
Decision Date1983-12-08
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CAPIJECT SYS CAPILLARY BLOOD COLLECT is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Medical Corp.. It received FDA 510(k) clearance on 1983-12-08 under 510(k) number K833475. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAPIJECT SYS CAPILLARY BLOOD COLLECT?

CAPIJECT SYS CAPILLARY BLOOD COLLECT is a medical device that received FDA 510(k) clearance on 1983-12-08. The listed applicant is Terumo Medical Corp.. The 510(k) number is K833475.

When did CAPIJECT SYS CAPILLARY BLOOD COLLECT receive FDA 510(k) clearance?

CAPIJECT SYS CAPILLARY BLOOD COLLECT received FDA 510(k) clearance on 1983-12-08, under 510(k) number K833475.

Who is the listed applicant for CAPIJECT SYS CAPILLARY BLOOD COLLECT?

The FDA 510(k) record lists Terumo Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAPIJECT SYS CAPILLARY BLOOD COLLECT?

The FDA product code for CAPIJECT SYS CAPILLARY BLOOD COLLECT is JKA.

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Other records listing Terumo Medical Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K111606PINNACLE PRECISION ACCESS SYSTEMK111556GLIDECROSS SUPPORT CATHETERK110540TERUMO SUPPORT CATHETERK102008GLIDESHEATHK091329PINNACLE DESTINATION PERIPHERAL GUIDING SHEATHK082997TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER

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Related Devices (Code: JKA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262215Profoject™ Safety Sliding Blood Collection SetCMT Health PTE., Ltd.K252899Female Culture Device; Male Culture Device; Transfer Device; Access DeviceZhejiang Kindly Medical Device Co., Ltd.K260128BD Preset™ and BD A-Line™ Arterial Blood Collection SyringesBecton, Dickinson and CompanyK252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection TubeBecton, Dickinson and CompanyK252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached HolderBecton, Dickinson and CompanyK252040BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection TubesBecton, Dickinson and Company

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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