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FDA 510(k)

Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)

K-Number: K223612 · 2023-02-21

ApplicantRanfac Corporation
Decision Date2023-02-21
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA) is a medical device manufactured by Ranfac Corporation. It received FDA 510(k) clearance on 2023-02-21 under approval number K223612. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)?

Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA) is a medical device that received FDA 510(k) clearance on 2023-02-21. It is manufactured by Ranfac Corporation. The 510(k) number is K223612.

When was Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA) approved by the FDA?

Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA) received FDA 510(k) clearance on 2023-02-21, under approval number K223612.

What company makes Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)?

Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA) is manufactured by Ranfac Corporation.

What is the FDA product code for Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)?

The FDA product code for Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA) is KNW.

Related Clinical Trials

NCT07548151 Guided Needle Insertion for Vascular Access COMPLETED NCT02299102 Comparing Powered Ported Bone Marrow Aspiration to Manual Standard Bone Marrow Aspiration Procedures COMPLETED NCT07577232 Transoral Ultrasound Versus no Transoral Ultrasound in Diagnostic Workup of Peritonsillar Abscess RECRUITING NCT06547632 ClearPetra™ Vacuum-assisted Ureteral Access Sheath vs Traditional Approach TERMINATED NCT05078853 Thyroglobulin Point of Care Assay for Rapid Detection of Metastatic Differentiated Thyroid Carcinoma COMPLETED NCT06358391 To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access. RECRUITING

Other Devices by Ranfac Corporation

K190177J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle, K183146Ranfac Cartilage Biopsy Needle K202287Ran-Flex-B Bone Marrow Aspiration Needle

Related Devices (Code: KNW)

K160316SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer NeedlesM.D.L. S.R.L. K153709Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer StyletDevicor Medical Products, Inc. K161234CASSI II Rotational Core Biopsy SystemScion Medical Technologies, LLC K161409M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for SemMermaid Medical A/S K161805EnCor MRI Introducer Set, EnCor Probe IntroducerSenorx, Inc. K153337Corvocet Biopsy SystemMerit Medical Systems, Inc.

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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