FDA 510(k)

Reprocessed ViewFlex™ Xtra ICE Catheter

Numéro K : K190478 · 2019-11-14

Date de décision2019-11-14

Code produitOWQ

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

Reprocessed ViewFlex™ Xtra ICE Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Sterilmed, Inc.. It received FDA 510(k) clearance on 2019-11-14 under 510(k) number K190478. The device is classified under product code OWQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Reprocessed ViewFlex™ Xtra ICE Catheter?

Reprocessed ViewFlex™ Xtra ICE Catheter is a medical device that received FDA 510(k) clearance on 2019-11-14. The listed applicant is Sterilmed, Inc.. The 510(k) number is K190478.

When did Reprocessed ViewFlex™ Xtra ICE Catheter receive FDA 510(k) clearance?

Reprocessed ViewFlex™ Xtra ICE Catheter received FDA 510(k) clearance on 2019-11-14, under 510(k) number K190478.

Who is the listed applicant for Reprocessed ViewFlex™ Xtra ICE Catheter?

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

What is the FDA product code for Reprocessed ViewFlex™ Xtra ICE Catheter?

The FDA product code for Reprocessed ViewFlex™ Xtra ICE Catheter is OWQ.

Essais cliniques associés

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Autres dossiers indiquant Sterilmed, Inc. en tant que demandeur

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Dispositifs connexes (Code : OWQ)

K254149Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485)Sterilmed, Inc.K250545Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)Surgical Instrument Service and Savings, Inc.K250592NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)Northeast Scientific, Inc.K243101Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342)Surgical Instrument Service and Savings, Inc.K234064Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for GE Systems) (10135910)Surgical Instrument Service and Savings, Inc.K232130Medline ReNewal Reprocessed ViewFlex Xtra ICE CatheterSurgical Instrument Services and Savings, Inc.

Source officielle

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