Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Certa Catheter

K-Number: K171193 · 2017-12-18

ApplicantFerrosan Medical Devices Sp. Z.O.O.
Decision Date2017-12-18
Product CodeBSO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Certa Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Ferrosan Medical Devices Sp. Z.O.O.. It received FDA 510(k) clearance on 2017-12-18 under 510(k) number K171193. 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 Certa Catheter?

Certa Catheter is a medical device that received FDA 510(k) clearance on 2017-12-18. The listed applicant is Ferrosan Medical Devices Sp. Z.O.O.. The 510(k) number is K171193.

When did Certa Catheter receive FDA 510(k) clearance?

Certa Catheter received FDA 510(k) clearance on 2017-12-18, under 510(k) number K171193.

Who is the listed applicant for Certa Catheter?

The FDA 510(k) record lists Ferrosan Medical Devices Sp. Z.O.O. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Certa Catheter?

The FDA product code for Certa Catheter is BSO.

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.

↑