FDA 510(k)

MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE

K-Number: K863418 · 1986-09-24

Decision Date1986-09-24

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics, Inc.. It received FDA 510(k) clearance on 1986-09-24 under 510(k) number K863418. The device is classified under product code DXY. It was reviewed by the CV advisory panel. Product code DXY falls under the category of Clinical Chemistry, which covers reagents and instruments for chemical analysis of clinical samples. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE?

MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE is a medical device that received FDA 510(k) clearance on 1986-09-24. The listed applicant is Intermedics, Inc.. The 510(k) number is K863418.

When did MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE receive FDA 510(k) clearance?

MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE received FDA 510(k) clearance on 1986-09-24, under 510(k) number K863418.

Who is the listed applicant for MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE?

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

What is the FDA product code for MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE?

The FDA product code for MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE is DXY. This falls under the Clinical Chemistry category.

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Other records listing Intermedics, Inc. as applicant

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Related Devices (Code: DXY)

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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.