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FDA 510(k)

Reprocessed ViewFlex Xtra ICE Catheter (D087031)

Numéro K : K231621 · 2023-07-25

DemandeurStryker Sustainability Solutions
Date de décision2023-07-25
Code produitOWQ
Comité consultatifCV
DécisionSubstantially Equivalent

Résumé du dispositif

Reprocessed ViewFlex Xtra ICE Catheter (D087031) is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Sustainability Solutions. It received FDA 510(k) clearance on 2023-07-25 under 510(k) number K231621. 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 (D087031)?

Reprocessed ViewFlex Xtra ICE Catheter (D087031) is a medical device that received FDA 510(k) clearance on 2023-07-25. The listed applicant is Stryker Sustainability Solutions. The 510(k) number is K231621.

When did Reprocessed ViewFlex Xtra ICE Catheter (D087031) receive FDA 510(k) clearance?

Reprocessed ViewFlex Xtra ICE Catheter (D087031) received FDA 510(k) clearance on 2023-07-25, under 510(k) number K231621.

Who is the listed applicant for Reprocessed ViewFlex Xtra ICE Catheter (D087031)?

The FDA 510(k) record lists Stryker Sustainability Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reprocessed ViewFlex Xtra ICE Catheter (D087031)?

The FDA product code for Reprocessed ViewFlex Xtra ICE Catheter (D087031) is OWQ.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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Autres dossiers indiquant Stryker Sustainability Solutions en tant que demandeur

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

K260636Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingK250898Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm); Reprocessed HARMONIC 700 Shears (HAR736/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 36cm); Reprocessed HARMONIC 700 Shears (HAR745/Reprocessed HARMONIC 700, 5mm Diameter SHears with Advanced Hemostasis x 45cm)K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001); Reprocessed RD SET Inf Pulse Oximeter Sensor (4002); Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)K241606Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136)K233471Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136)K230251Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)

Voir tous les 25 dispositifs →

Dispositifs connexes (Code : OWQ)

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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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