FDA 510(k)

INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (HEPARIN COATED)

K-Number: K980578 · 1998-09-11

Decision Date1998-09-11

Product CodeDYB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (HEPARIN COATED) is the device name listed in this FDA 510(k) record. The listed applicant is Innerdyne, Inc.. It received FDA 510(k) clearance on 1998-09-11 under 510(k) number K980578. 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 (HEPARIN COATED)?

INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (HEPARIN COATED) is a medical device that received FDA 510(k) clearance on 1998-09-11. The listed applicant is Innerdyne, Inc.. The 510(k) number is K980578.

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

INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (HEPARIN COATED) received FDA 510(k) clearance on 1998-09-11, under 510(k) number K980578.

Who is the listed applicant for INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (HEPARIN COATED)?

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 (HEPARIN COATED)?

The FDA product code for INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (HEPARIN COATED) 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 K972684INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM 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.