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FDA 510(k)

PAINFUSOR CATHETER

K-Number: K111031 · 2011-07-08

ApplicantPlan 1 Health, S.R.L.
Decision Date2011-07-08
Product CodeBSO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PAINFUSOR CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Plan 1 Health, S.R.L.. It received FDA 510(k) clearance on 2011-07-08 under 510(k) number K111031. 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 PAINFUSOR CATHETER?

PAINFUSOR CATHETER is a medical device that received FDA 510(k) clearance on 2011-07-08. The listed applicant is Plan 1 Health, S.R.L.. The 510(k) number is K111031.

When did PAINFUSOR CATHETER receive FDA 510(k) clearance?

PAINFUSOR CATHETER received FDA 510(k) clearance on 2011-07-08, under 510(k) number K111031.

Who is the listed applicant for PAINFUSOR CATHETER?

The FDA 510(k) record lists Plan 1 Health, S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PAINFUSOR CATHETER?

The FDA product code for PAINFUSOR CATHETER is BSO.

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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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

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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