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FDA 510(k)

IVAS 20MM (10 GAUGE) BALLOON CATHETER

K-Number: K113477 · 2012-01-06

ApplicantStryker Instruments, Instruments Div.
Decision Date2012-01-06
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IVAS 20MM (10 GAUGE) BALLOON CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Instruments, Instruments Div.. It received FDA 510(k) clearance on 2012-01-06 under 510(k) number K113477. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IVAS 20MM (10 GAUGE) BALLOON CATHETER?

IVAS 20MM (10 GAUGE) BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 2012-01-06. The listed applicant is Stryker Instruments, Instruments Div.. The 510(k) number is K113477.

When did IVAS 20MM (10 GAUGE) BALLOON CATHETER receive FDA 510(k) clearance?

IVAS 20MM (10 GAUGE) BALLOON CATHETER received FDA 510(k) clearance on 2012-01-06, under 510(k) number K113477.

Who is the listed applicant for IVAS 20MM (10 GAUGE) BALLOON CATHETER?

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

What is the FDA product code for IVAS 20MM (10 GAUGE) BALLOON CATHETER?

The FDA product code for IVAS 20MM (10 GAUGE) BALLOON CATHETER is NDN.

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Other records listing Stryker Instruments, Instruments Div. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K123178STRYKER VENOM ELECTRODES AND CANNULAEK093419IVAS 2-10MM (10 GAUGE) BALLOON CATHETER, IVAS 2-15 MM(10 GAUGE)0705-115-500, IVAS 3-10MM(8 GAUGE)BALLOON CATHETER, IVASK072702STRYKER ANTIMIC CATHETERK073017STRYKER STRI-SHIELD FLYTE TOGASK070078STRYKER T4 HYTREL TOGA

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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