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FDA 510(k)

HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS)

K-Number: K132883 · 2013-11-01

ApplicantHemodia Sas
Decision Date2013-11-01
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS) is the device name listed in this FDA 510(k) record. The listed applicant is Hemodia Sas. It received FDA 510(k) clearance on 2013-11-01 under 510(k) number K132883. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS)?

HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS) is a medical device that received FDA 510(k) clearance on 2013-11-01. The listed applicant is Hemodia Sas. The 510(k) number is K132883.

When did HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS) receive FDA 510(k) clearance?

HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS) received FDA 510(k) clearance on 2013-11-01, under 510(k) number K132883.

Who is the listed applicant for HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS)?

The FDA 510(k) record lists Hemodia Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS)?

The FDA product code for HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS) is HRX.

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Other records listing Hemodia Sas 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.

K221919DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing setsK203480DOUBLEFLO systemK192921Zeos Aqua Vision Pump and tube

Related Devices (Code: HRX)

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.

K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd.K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KGK252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLCK253523Freedom DS™ Decompression SystemSpinal SimplicityK252546VantageTM Lumbar Decompression KitAllevion Medical, LLCK253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)

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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