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U.S. FDA Medical Device Suction Catheter & Tip Requirements

FDA Medical Device Definition: A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).

Registrar Corp assists Suction Catheter & Tip companies with:

  • FDA Suction Catheter & Tip Establishment Registration
  • FDA Suction Catheter & Tip Listing
  • FDA Suction Catheter & Tip Label Requirements and Exceptions
  • FDA Suction Catheter & Tip Import Information
  • FDA Suction Catheter & Tip Detentions (Suction Catheter & Tip Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Suction Catheter & Tip Manufacturers (Suction Catheter & Tip Suppliers)
       - Suction Catheter & Tip Distributors
       - Suction Catheter & Tip Processors
       - Suction Catheter & Tip Repackers
       - Suction Catheter & Tip Relabelers
       - Suction Catheter & Tip Exporters
       - Suction Catheter & Tip Importers
For more information about Suction Catheter & Tip Medical Devices, simply click below:

U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.

Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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