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FDA 510(k)

MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE

K-Number: K013683 · 2001-12-06

ApplicantAbbott Vascular, Inc.
Decision Date2001-12-06
Product CodeGAW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Vascular, Inc.. It received FDA 510(k) clearance on 2001-12-06 under 510(k) number K013683. The device is classified under product code GAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE?

MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE is a medical device that received FDA 510(k) clearance on 2001-12-06. The listed applicant is Abbott Vascular, Inc.. The 510(k) number is K013683.

When did MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE receive FDA 510(k) clearance?

MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE received FDA 510(k) clearance on 2001-12-06, under 510(k) number K013683.

Who is the listed applicant for MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE?

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

What is the FDA product code for MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE?

The FDA product code for MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE is GAW.

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Related Devices (Code: GAW)

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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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