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FDA 510(k)

DISCYPHOR CATHETER SYSTEM, MODEL D01A; DISCYPHOR INTRODUCER NEEDLE, MODEL D01B

K-Number: K063071 · 2007-04-13

ApplicantKyphon, Inc.
Decision Date2007-04-13
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DISCYPHOR CATHETER SYSTEM, MODEL D01A; DISCYPHOR INTRODUCER NEEDLE, MODEL D01B is the device name listed in this FDA 510(k) record. The listed applicant is Kyphon, Inc.. It received FDA 510(k) clearance on 2007-04-13 under 510(k) number K063071. 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 CATHETER SYSTEM, MODEL D01A; DISCYPHOR INTRODUCER NEEDLE, MODEL D01B?

DISCYPHOR CATHETER SYSTEM, MODEL D01A; DISCYPHOR INTRODUCER NEEDLE, MODEL D01B is a medical device that received FDA 510(k) clearance on 2007-04-13. The listed applicant is Kyphon, Inc.. The 510(k) number is K063071.

When did DISCYPHOR CATHETER SYSTEM, MODEL D01A; DISCYPHOR INTRODUCER NEEDLE, MODEL D01B receive FDA 510(k) clearance?

DISCYPHOR CATHETER SYSTEM, MODEL D01A; DISCYPHOR INTRODUCER NEEDLE, MODEL D01B received FDA 510(k) clearance on 2007-04-13, under 510(k) number K063071.

Who is the listed applicant for DISCYPHOR CATHETER SYSTEM, MODEL D01A; DISCYPHOR INTRODUCER NEEDLE, MODEL D01B?

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 CATHETER SYSTEM, MODEL D01A; DISCYPHOR INTRODUCER NEEDLE, MODEL D01B?

The FDA product code for DISCYPHOR CATHETER SYSTEM, MODEL D01A; DISCYPHOR INTRODUCER NEEDLE, MODEL D01B is BSP.

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Other records listing Kyphon, Inc. as applicant

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.

K073516DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULARK061210FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) CATHETER SYSTEM, MODEL D01A ; INTRODUCER NEEDLE, MODEL D01BK041454KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13AK041584KYPHX HV-R BONE CEMENT, MODEL C01AK033801KYPHX HV-R, MODEL C01AK032212KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A

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Related Devices (Code: BSP)

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.

K243690SonoMSKPAJUNK GmbH MedizintechnologieK243682SonoPlex STIM; SonoPlex IIPAJUNK GmbH MedizintechnologieK250774SPROTTE® STANDARD (LUER/ NRFit®) Lumbar PuncturePAJUNK GmbH MedizintechnologieK243525SonoTAP and SonoTAP IIPAJUNK GmbH MedizintechnologieK241953SPROTTE® STANDARD (LUER/ NRFit®) AnesthesiologyPAJUNK GmbH MedizintechnologieK241954SonoBlock; SonoBlock IIPAJUNK GmbH Medizintechnologie

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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