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FDA 510(k)

S3086 ARTERIAL, S3087 VENOUS NEONATAL HEMODIALYSIS

K-Number: K873455 · 1987-09-14

ApplicantDravon Medical, Inc.
Decision Date1987-09-14
Product CodeFJK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

S3086 ARTERIAL, S3087 VENOUS NEONATAL HEMODIALYSIS is the device name listed in this FDA 510(k) record. The listed applicant is Dravon Medical, Inc.. It received FDA 510(k) clearance on 1987-09-14 under 510(k) number K873455. The device is classified under product code FJK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S3086 ARTERIAL, S3087 VENOUS NEONATAL HEMODIALYSIS?

S3086 ARTERIAL, S3087 VENOUS NEONATAL HEMODIALYSIS is a medical device that received FDA 510(k) clearance on 1987-09-14. The listed applicant is Dravon Medical, Inc.. The 510(k) number is K873455.

When did S3086 ARTERIAL, S3087 VENOUS NEONATAL HEMODIALYSIS receive FDA 510(k) clearance?

S3086 ARTERIAL, S3087 VENOUS NEONATAL HEMODIALYSIS received FDA 510(k) clearance on 1987-09-14, under 510(k) number K873455.

Who is the listed applicant for S3086 ARTERIAL, S3087 VENOUS NEONATAL HEMODIALYSIS?

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

What is the FDA product code for S3086 ARTERIAL, S3087 VENOUS NEONATAL HEMODIALYSIS?

The FDA product code for S3086 ARTERIAL, S3087 VENOUS NEONATAL HEMODIALYSIS is FJK.

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Other records listing Dravon Medical, Inc. as applicant

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Related Devices (Code: FJK)

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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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