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FDA 510(k)

DUAL-CANNULA SYSTEM ACC. MANCAO, SPECIAL SPROTTE

K-Number: K063350 · 2008-02-01

ApplicantPAJUNK GmbH Medizintechnologie
Decision Date2008-02-01
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DUAL-CANNULA SYSTEM ACC. MANCAO, SPECIAL SPROTTE is the device name listed in this FDA 510(k) record. The listed applicant is PAJUNK GmbH Medizintechnologie. It received FDA 510(k) clearance on 2008-02-01 under 510(k) number K063350. 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 DUAL-CANNULA SYSTEM ACC. MANCAO, SPECIAL SPROTTE?

DUAL-CANNULA SYSTEM ACC. MANCAO, SPECIAL SPROTTE is a medical device that received FDA 510(k) clearance on 2008-02-01. The listed applicant is PAJUNK GmbH Medizintechnologie. The 510(k) number is K063350.

When did DUAL-CANNULA SYSTEM ACC. MANCAO, SPECIAL SPROTTE receive FDA 510(k) clearance?

DUAL-CANNULA SYSTEM ACC. MANCAO, SPECIAL SPROTTE received FDA 510(k) clearance on 2008-02-01, under 510(k) number K063350.

Who is the listed applicant for DUAL-CANNULA SYSTEM ACC. MANCAO, SPECIAL SPROTTE?

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

What is the FDA product code for DUAL-CANNULA SYSTEM ACC. MANCAO, SPECIAL SPROTTE?

The FDA product code for DUAL-CANNULA SYSTEM ACC. MANCAO, SPECIAL SPROTTE is BSP.

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Other records listing PAJUNK GmbH Medizintechnologie 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.

K243690SonoMSKK243682SonoPlex STIM; SonoPlex IIK250774SPROTTE® STANDARD (LUER/ NRFit®) Lumbar PunctureK243525SonoTAP and SonoTAP IIK241953SPROTTE® STANDARD (LUER/ NRFit®) AnesthesiologyK241954SonoBlock; SonoBlock II

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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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