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FDA 510(k)

OPN NC PTCA Dilatation Catheter

K-Number: K212393 · 2022-03-14

ApplicantSis Medical AG
Decision Date2022-03-14
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OPN NC PTCA Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Sis Medical AG. It received FDA 510(k) clearance on 2022-03-14 under 510(k) number K212393. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPN NC PTCA Dilatation Catheter?

OPN NC PTCA Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2022-03-14. The listed applicant is Sis Medical AG. The 510(k) number is K212393.

When did OPN NC PTCA Dilatation Catheter receive FDA 510(k) clearance?

OPN NC PTCA Dilatation Catheter received FDA 510(k) clearance on 2022-03-14, under 510(k) number K212393.

Who is the listed applicant for OPN NC PTCA Dilatation Catheter?

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

What is the FDA product code for OPN NC PTCA Dilatation Catheter?

The FDA product code for OPN NC PTCA Dilatation Catheter is LOX.

Related Devices (Code: LOX)

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.

K261428NC Euphora Rapid Exchange Balloon Dilatation CatheterMedtronic IrelandK261759Euphora Rapid Exchange (RX) Balloon Dilatation CatheterMedtronic IrelandK252116Firefighter™ Pro PTCA Balloon CatheterShanghai MicroPort Medical (Group) Co., Ltd.K254022FLASH Flex™ Aorto-Ostial Angioplasty SystemVerge Medical, Inc.K252295RyureiTerumo CorporationK251970Sprinter Legend Rapid Exchange Balloon Dilatation CatheterMedtronic, Ireland

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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