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FDA 510(k)

SUBDURAL DRAINAGE CATHETER KIT, SUBDURAL CATHETER

K-Number: K974726 · 1998-03-18

ApplicantElekta Implants, SA
Decision Date1998-03-18
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SUBDURAL DRAINAGE CATHETER KIT, SUBDURAL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Elekta Implants, SA. It received FDA 510(k) clearance on 1998-03-18 under 510(k) number K974726. 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 SUBDURAL DRAINAGE CATHETER KIT, SUBDURAL CATHETER?

SUBDURAL DRAINAGE CATHETER KIT, SUBDURAL CATHETER is a medical device that received FDA 510(k) clearance on 1998-03-18. The listed applicant is Elekta Implants, SA. The 510(k) number is K974726.

When did SUBDURAL DRAINAGE CATHETER KIT, SUBDURAL CATHETER receive FDA 510(k) clearance?

SUBDURAL DRAINAGE CATHETER KIT, SUBDURAL CATHETER received FDA 510(k) clearance on 1998-03-18, under 510(k) number K974726.

Who is the listed applicant for SUBDURAL DRAINAGE CATHETER KIT, SUBDURAL CATHETER?

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

What is the FDA product code for SUBDURAL DRAINAGE CATHETER KIT, SUBDURAL CATHETER?

The FDA product code for SUBDURAL DRAINAGE CATHETER KIT, SUBDURAL CATHETER is JXG.

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 Elekta Implants, SA 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.

K971799PRECISION FLOW OSV II

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Official Source

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