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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 a medical device manufactured by Pan Medical , Ltd.. It received FDA 510(k) clearance on 2016-11-01 under approval 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. It is manufactured by Pan Medical , Ltd.. The 510(k) number is K162453.

When was 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex) approved by the FDA?

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

What company makes 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 manufactured by Pan Medical , Ltd..

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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Related Devices (Code: NDN)

K160983Kyphon HV-R Bone CementMedtronic, Inc. K153296MEDINAUT Kyphoplasty SystemImedicom Co., Ltd. K152557Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon CathetersG21, S.R.L. K172214Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon CathetersG-21 S.R.L. K161114HIGH V+Teknimed Sas K163032Kyphon Xpede Bone CementMedtronic, Inc.

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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