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FDA 510(k)

PS MEDICAL CSF-ON/OFF FLUSHING RESERVOIR

K-Number: K896167 · 1989-12-21

ApplicantPudenz-Schulte Medical Research Corp.
Decision Date1989-12-21
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PS MEDICAL CSF-ON/OFF FLUSHING RESERVOIR is the device name listed in this FDA 510(k) record. The listed applicant is Pudenz-Schulte Medical Research Corp.. It received FDA 510(k) clearance on 1989-12-21 under 510(k) number K896167. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PS MEDICAL CSF-ON/OFF FLUSHING RESERVOIR?

PS MEDICAL CSF-ON/OFF FLUSHING RESERVOIR is a medical device that received FDA 510(k) clearance on 1989-12-21. The listed applicant is Pudenz-Schulte Medical Research Corp.. The 510(k) number is K896167.

When did PS MEDICAL CSF-ON/OFF FLUSHING RESERVOIR receive FDA 510(k) clearance?

PS MEDICAL CSF-ON/OFF FLUSHING RESERVOIR received FDA 510(k) clearance on 1989-12-21, under 510(k) number K896167.

Who is the listed applicant for PS MEDICAL CSF-ON/OFF FLUSHING RESERVOIR?

The FDA 510(k) record lists Pudenz-Schulte Medical Research Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PS MEDICAL CSF-ON/OFF FLUSHING RESERVOIR?

The FDA product code for PS MEDICAL CSF-ON/OFF FLUSHING RESERVOIR is JXG.

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Other records listing Pudenz-Schulte Medical Research Corp. 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.

K960055MEDTRONIC PS MEDICAL BIOGLIDE VASCULAR CATHETER, SNGL LUMEN MODEL NOS 8960 & 8932K954409PS MEDICAL IPI VASCULAR ACCESS CATHETERK951258PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KITK934167IPI DUAL LUMEN PORTK934796IPI LOW PROFILE IMPORTK940096PS MEDICAL CATHETER PLACEMENT KIT

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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.

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