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FDA 510(k)

Pencylcap

K-Number: K152050 · 2016-03-02

ApplicantB.Braun Melsungen AG
Decision Date2016-03-02
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Pencylcap is the device name listed in this FDA 510(k) record. The listed applicant is B.Braun Melsungen AG. It received FDA 510(k) clearance on 2016-03-02 under 510(k) number K152050. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pencylcap?

Pencylcap is a medical device that received FDA 510(k) clearance on 2016-03-02. The listed applicant is B.Braun Melsungen AG. The 510(k) number is K152050.

When did Pencylcap receive FDA 510(k) clearance?

Pencylcap received FDA 510(k) clearance on 2016-03-02, under 510(k) number K152050.

Who is the listed applicant for Pencylcap?

The FDA 510(k) record lists B.Braun Melsungen AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pencylcap?

The FDA product code for Pencylcap is FMI.

Related Clinical Trials

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.

NCT02460042Clinical Post Market Clinical Follow-up (PMCF) on Peripheral Arteries Treated With SeQuent® Please Over The Wire (OTW)COMPLETEDNCT04470934SeQuent® SCB "All Comers" Post Market Clinical Follow-up (PMCF)ACTIVE_NOT_RECRUITINGNCT07363161BASel Kosten-Effektivitäts-Trial: Drug-coated BALLoon (DCB) vs. Drug-eluting Stent (DES) Strategy in High-risk Patients With Coronary Artery Disease (CAD)RECRUITING

Other records listing B.Braun Melsungen AG 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.

K163358Introcan Safety 3 Closed IV Catheter

Related Devices (Code: FMI)

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.

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Official Source

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

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