FDA 510(k)

Ostial Sprit Cannulae

K-Number: K162500 · 2017-01-12

Decision Date2017-01-12

Product CodeDWF

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Ostial Sprit Cannulae is the device name listed in this FDA 510(k) record. The listed applicant is Spyder Medical. It received FDA 510(k) clearance on 2017-01-12 under 510(k) number K162500. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ostial Sprit Cannulae?

Ostial Sprit Cannulae is a medical device that received FDA 510(k) clearance on 2017-01-12. The listed applicant is Spyder Medical. The 510(k) number is K162500.

When did Ostial Sprit Cannulae receive FDA 510(k) clearance?

Ostial Sprit Cannulae received FDA 510(k) clearance on 2017-01-12, under 510(k) number K162500.

Who is the listed applicant for Ostial Sprit Cannulae?

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

What is the FDA product code for Ostial Sprit Cannulae?

The FDA product code for Ostial Sprit Cannulae is DWF.

Related Devices (Code: DWF)

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.

K260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeMedtronic, Inc.K250937Venous Return CannulaeLivaNova USA, Inc.K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart Reactors K253203Retrograde Coronary Sinus Perfusion CannulaeMedtronic, Inc.K253671Dual Stage Venous CannulaeSorin Group Italia S.R.L.K253998Clearview Intracoronary ShuntsMedtronic, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.