Silicraft Industrial Silicone Atelier
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Catheter Balloon
MG-002 · catheter-balloon

Catheter Balloon

Thin-wall, ±0.05 mm wall control

The Catheter Balloon is a thin-wall, ±0.05 mm wall control. We mold it by LSR dip / injection, Class 8 in a Shore A 30–50 compound, holding ±0.05 mm across production lots, and it complies with ISO 13485 · ISO 10993-5 · USP Class VI · EN ISO 10555. Typical minimum order is 2,000 pcs; series lead time is 28 days.

Thin-wall balloon sleeves with tightly controlled wall thickness so inflation pressure and profile are repeatable device to device. Available dipped or injection molded.

  • ±0.05 mm wall thickness
  • Repeatable inflation profile
  • EN ISO 10555 tested
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Specification

Hardness Shore A 30–50
Service temperature -50–180 °C
Achievable tolerance ±0.05 mm
Molding process LSR dip / injection, Class 8
Typical MOQ 2,000 pcs
Lead time 28 days

Compliance

  • ISO 13485
  • ISO 10993-5
  • USP Class VI
  • EN ISO 10555

Frequently asked about this part

What is the minimum order quantity for the Catheter Balloon?

Typically 2,000 pcs. Below that we can still quote, but tooling amortisation starts to dominate the unit price. Sampling and tooling are quoted separately from series production.

What is the lead time for the Catheter Balloon?

Series production runs 28 days after sample approval. Tool design and T1 sampling add 10–14 days up front, and DFM feedback on your drawing comes back within 48 hours.

What tolerance can you hold on the Catheter Balloon?

±0.05 mm is the achievable production tolerance for this part family. It covers the dimensions that matter for fit and sealing; we confirm which ones are critical in the DFM memo before tooling is cut.

Which standards does the Catheter Balloon comply with?

It is produced to ISO 13485 · ISO 10993-5 · USP Class VI · EN ISO 10555. Certificates and test reports are on file and can be forwarded once an NDA is in place.

How is the Catheter Balloon molded?

By LSR dip / injection, Class 8, in a cell dedicated to that silicone grade. Medical parts are never run on a line that has produced kitchenware — each grade keeps its own press, tooling and QC station.

What hardness and temperature range does the Catheter Balloon use?

Shore A 30–50, with a service range of -50–180 °C. If your application needs a different durometer in the same geometry, we can usually re-quote the compound without cutting new tooling.

Other products in this category

Medical Silicone O-Ring Medical Silicone O-Ring USP Class VI, Class 8 molded Respiratory Mask Cushion Respiratory Mask Cushion Ultra-soft face seal, 20–35 Shore A Medical Silicone Tourniquet Medical Silicone Tourniquet Latex-free, autoclavable strap Infusion Pump Tubing Infusion Pump Tubing DEHP-free, ±0.05 mm bore

Need this part quoted?

Send the drawing or a sample. DFM feedback and a quotation within two business days.

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