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FDA 510(k)

13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)

K-Number: K162453 · 2016-11-01

ApplicantPan Medical , Ltd.
Decision Date2016-11-01
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex) is the device name listed in this FDA 510(k) record. The listed applicant is Pan Medical , Ltd.. It received FDA 510(k) clearance on 2016-11-01 under 510(k) number K162453. 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 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)?

13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex) is a medical device that received FDA 510(k) clearance on 2016-11-01. The listed applicant is Pan Medical , Ltd.. The 510(k) number is K162453.

When did 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex) receive FDA 510(k) clearance?

13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex) received FDA 510(k) clearance on 2016-11-01, under 510(k) number K162453.

Who is the listed applicant for 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)?

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

What is the FDA product code for 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)?

The FDA product code for 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex) is NDN.

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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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