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FDA 510(k)

NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER

K-Number: K052083 · 2005-09-29

ApplicantBiosense Webster, Inc.
Decision Date2005-09-29
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Biosense Webster, Inc.. It received FDA 510(k) clearance on 2005-09-29 under 510(k) number K052083. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER?

NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER is a medical device that received FDA 510(k) clearance on 2005-09-29. The listed applicant is Biosense Webster, Inc.. The 510(k) number is K052083.

When did NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER receive FDA 510(k) clearance?

NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER received FDA 510(k) clearance on 2005-09-29, under 510(k) number K052083.

Who is the listed applicant for NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER?

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

What is the FDA product code for NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER?

The FDA product code for NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER is DRF.

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Related Devices (Code: DRF)

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.

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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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