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FDA 510(k)

SAFEPORT MANIFOLD (TM) (OR STOPCOCK)

K-Number: K111016 · 2011-06-09

ApplicantElcam Medical Acal
Decision Date2011-06-09
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SAFEPORT MANIFOLD (TM) (OR STOPCOCK) is the device name listed in this FDA 510(k) record. The listed applicant is Elcam Medical Acal. It received FDA 510(k) clearance on 2011-06-09 under 510(k) number K111016. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAFEPORT MANIFOLD (TM) (OR STOPCOCK)?

SAFEPORT MANIFOLD (TM) (OR STOPCOCK) is a medical device that received FDA 510(k) clearance on 2011-06-09. The listed applicant is Elcam Medical Acal. The 510(k) number is K111016.

When did SAFEPORT MANIFOLD (TM) (OR STOPCOCK) receive FDA 510(k) clearance?

SAFEPORT MANIFOLD (TM) (OR STOPCOCK) received FDA 510(k) clearance on 2011-06-09, under 510(k) number K111016.

Who is the listed applicant for SAFEPORT MANIFOLD (TM) (OR STOPCOCK)?

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

What is the FDA product code for SAFEPORT MANIFOLD (TM) (OR STOPCOCK)?

The FDA product code for SAFEPORT MANIFOLD (TM) (OR STOPCOCK) is FPA.

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.

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Other records listing Elcam Medical Acal 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.

K231900A-TAP (previously called Arthrotap)K211204SafePort(TM) Manifold (or Stopcock)K190489Elcam Stopcocks and ManifoldsK123084DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLDK120253ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS)K120624ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT)

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Related Devices (Code: FPA)

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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)

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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