FDA 510(k)

DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULAR

K-Number: K073516 · 2008-02-21

Decision Date2008-02-21

Product CodeBSP

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULAR is the device name listed in this FDA 510(k) record. The listed applicant is Kyphon, Inc.. It received FDA 510(k) clearance on 2008-02-21 under 510(k) number K073516. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULAR?

DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULAR is a medical device that received FDA 510(k) clearance on 2008-02-21. The listed applicant is Kyphon, Inc.. The 510(k) number is K073516.

When did DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULAR receive FDA 510(k) clearance?

DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULAR received FDA 510(k) clearance on 2008-02-21, under 510(k) number K073516.

Who is the listed applicant for DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULAR?

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

What is the FDA product code for DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULAR?

The FDA product code for DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULAR is BSP.

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Other records listing Kyphon, Inc. as applicant

K063071DISCYPHOR CATHETER SYSTEM, MODEL D01A; DISCYPHOR INTRODUCER NEEDLE, MODEL D01B K061210FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) CATHETER SYSTEM, MODEL D01A ; INTRODUCER NEEDLE, MODEL D01B K041454KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A K041584KYPHX HV-R BONE CEMENT, MODEL C01A K033801KYPHX HV-R, MODEL C01A K032212KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A

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Related Devices (Code: BSP)

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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.