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510(k) K871263

MULTIPLE PHARMA-PLAST TRACHEAL TUBE by Pharma-Plast USA, Inc. — Product Code BTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1987
Date Received
March 31, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheal (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5730
Review Panel
AN
Submission Type

Other clearances by Pharma-Plast USA, Inc.

  • K894371 — NIPRO SAFELET CATH (October 25, 1989)
  • K894373 — NIPRO DENTAL NEEDLE (October 13, 1989)
  • K894372 — NIPRO NEEDLE HOLDER (September 28, 1989)
  • K894374 — BLOOD DRAWING NEEDLE (September 28, 1989)
  • K884978 — PHARMA-PLAST INSULIN INFUSION SET (June 21, 1989)
  • K852443 — PHARMA-PLAST CLINIPAK (October 16, 1985)
  • K852444 — ASIK 'ONCE' SYRINGE (October 16, 1985)
  • K852442 — PHARMA-PLAST NEEDLE (September 20, 1985)

Other clearances for product code BTR

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  • K243579 — AeroJet Ventilation Catheter (August 13, 2025)
  • K251499 — Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C- (June 11, 2025)
  • K250243 — ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); (May 20, 2025)
  • K242495 — LMA Fastrach ETT SU (April 29, 2025)
  • K241451 — Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); (February 11, 2025)
  • K233341 — Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, (May 20, 2024)
  • K223130 — Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP ( (August 30, 2023)
  • K211543 — Wei Nasal Jet Tube (July 21, 2022)