FDA 510(k)

INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM

K-Number: K972684 · 1997-10-10

Decision Date1997-10-10

Product CodeDYB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Innerdyne, Inc.. It received FDA 510(k) clearance on 1997-10-10 under 510(k) number K972684. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM?

INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM is a medical device that received FDA 510(k) clearance on 1997-10-10. The listed applicant is Innerdyne, Inc.. The 510(k) number is K972684.

When did INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM receive FDA 510(k) clearance?

INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM received FDA 510(k) clearance on 1997-10-10, under 510(k) number K972684.

Who is the listed applicant for INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM?

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

What is the FDA product code for INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM?

The FDA product code for INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM is DYB.

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Other records listing Innerdyne, Inc. as applicant

K992668INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (REVAS)K990854INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE K990493INNERDYNE GENERIC RADIALLY EXPANDING DILATION, G-RED DEVICE K982417INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP K980578INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (HEPARIN COATED)K971230SHERWOOD MEDICAL COMPANY , KANGAROO, ENTRISTAR, PERCUTANEOUS GASTROSTOMY 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.