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FDA 510(k)

PERF-GEN PULSATILE PERFUSION SOLUTION

K-Number: K121736 · 2013-08-16

ApplicantWaters Medical Systems, LLC
Decision Date2013-08-16
Product CodeKDL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PERF-GEN PULSATILE PERFUSION SOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Waters Medical Systems, LLC. It received FDA 510(k) clearance on 2013-08-16 under 510(k) number K121736. The device is classified under product code KDL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERF-GEN PULSATILE PERFUSION SOLUTION?

PERF-GEN PULSATILE PERFUSION SOLUTION is a medical device that received FDA 510(k) clearance on 2013-08-16. The listed applicant is Waters Medical Systems, LLC. The 510(k) number is K121736.

When did PERF-GEN PULSATILE PERFUSION SOLUTION receive FDA 510(k) clearance?

PERF-GEN PULSATILE PERFUSION SOLUTION received FDA 510(k) clearance on 2013-08-16, under 510(k) number K121736.

Who is the listed applicant for PERF-GEN PULSATILE PERFUSION SOLUTION?

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

What is the FDA product code for PERF-GEN PULSATILE PERFUSION SOLUTION?

The FDA product code for PERF-GEN PULSATILE PERFUSION SOLUTION is KDL.

Related Clinical Trials

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.

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Other records listing Waters Medical Systems, LLC 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.

K121618BEL-GEN COLD STORAGE SOLUTIONK111521WAVES

Related Devices (Code: KDL)

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.

K241239OrganProtex HTK SolutionBridge TO Life, Ltd.K221386PERF-GEN Pulsatile Perfusion SolutionInstitut Georges LopezK221387BEL-GEN Cold Storage SolutionInstitut Georges LopezK211842Servator M SALF SolutionS.A.L.F. SpaK192408Custodiol HTK SolutionDr. Franz Kohler Chemie GmbHK170150Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bagsS.A.L.F. Spa

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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