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510(k) K203394

PleuraFlow System with FlowGlide by Clearflow, Inc. — Product Code OTK

K203394 is an FDA 510(k) premarket notification submitted by Clearflow, Inc. for the device "PleuraFlow System with FlowGlide". The FDA issued a decision of Substantially Equivalent on March 2, 2021. The device falls under product code OTK (Wound Drain Catheter System), a Class II device regulated under 21 CFR 878.4780. Clearflow, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2021
Date Received
November 18, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wound Drain Catheter System
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type

For use as an adjunctive device during open surgical procedures in order to prevent fluid accumulation within the operative site after closure of the surgical wound. The device is indicated for use in thoracic surgical procedures.

Other clearances by Clearflow, Inc.

  • K191733 — The ZIP Accessory Shuttle for PleuraFlow System (July 26, 2019)
  • K182067 — PleuraFlow System with FlowGlide Extra Drainage Length (August 14, 2018)
  • K163139 — PleuraFlow System with FlowGlide (November 30, 2016)
  • K153681 — PleuraFlow System (January 20, 2016)
  • K150042 — PleuraFlow System (June 2, 2015)

Other clearances for product code OTK

  • K191733 — The ZIP Accessory Shuttle for PleuraFlow System (July 26, 2019)
  • K182067 — PleuraFlow System with FlowGlide Extra Drainage Length (August 14, 2018)
  • K163139 — PleuraFlow System with FlowGlide (November 30, 2016)
  • K153681 — PleuraFlow System (January 20, 2016)
  • K150042 — PleuraFlow System (June 2, 2015)
  • K093565 — PLEURAFLOW CATHETER SYSTEM (December 3, 2010)

FDA data resources