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FDA 510(k)

AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH

K-Number: K102460 · 2011-01-13

ApplicantSummit Medical Products, Inc.
Decision Date2011-01-13
Product CodeBSO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Summit Medical Products, Inc.. It received FDA 510(k) clearance on 2011-01-13 under 510(k) number K102460. The device is classified under product code BSO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH?

AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH is a medical device that received FDA 510(k) clearance on 2011-01-13. The listed applicant is Summit Medical Products, Inc.. The 510(k) number is K102460.

When did AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH receive FDA 510(k) clearance?

AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH received FDA 510(k) clearance on 2011-01-13, under 510(k) number K102460.

Who is the listed applicant for AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH?

The FDA 510(k) record lists Summit Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH?

The FDA product code for AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH is BSO.

Related Clinical Trials

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Other records listing Summit Medical Products, Inc. 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.

K162165ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent PumpK113043DIRECT ANTIBIOTIC INFUSION KITK110814AMBIT TUNNELER

Related Devices (Code: BSO)

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.

K241410EDEN ControlCathJmt Co., Ltd.K231242Perifix FX Catheter; Contiplex FX CatheterB.Braun Medical, Inc.K230603Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002)Teleflex MedicalK193664SubQKath Catheter and Needle SetHk SurgicalK200624Percutaneous IntroducerEpimed International, Inc.K191470C-CAT Anaesthesia Catheter kitCimpax Aps

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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