Epineed Epidural Catheter
FDA 510(k) K832232 · Terumo Medical Corp.
510(k) numberK832232
Submission
- Device name
- Epineed Epidural Catheter
- Applicant
- Terumo Medical Corp.
Elkton, MD, US - Received
- July 11, 1983
- Decision date
- August 8, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BSO – Catheter, Conduction, Anesthetic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5120
- Specialty
- Anesthesiology
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| K181782 | Medline Reinforced Epidural CatheterBSO · Traditional | Medline Industries, Inc. | 03/04/2019SE |
| K173541 | EpinautBSO · Traditional | Imedicom Co., Ltd. | 08/24/2018SE |
| K172777 | Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7BSO · Traditional | PAJUNK GmbH Medizintechnologie | 05/03/2018SE |
| K171584 | B. Braun Tear-Away Introducer NeedleBSO · Traditional | B.Braun Medical, Inc. | 12/22/2017SE |
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| 510(k) | Device | Decision |
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| K173831 | Glidesheath SlenderDYB · Traditional | 05/08/2018SE |
| K172995 | Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination…DYB · Traditional | 11/21/2017SE |
| K171491 | R2P Destination Slender Guiding SheathDYB · Traditional | 10/05/2017SE |
| K152173 | GlidesheathDYB · Traditional | 12/01/2015SE |
| K152525 | TR BAND Radial Compression DeviceDXC · Traditional | 11/10/2015SE |
| K151471 | Radifocus Glidewire Endoscopic WireOCY · Traditional | 09/17/2015SE |
Questions and answers
When was Epineed Epidural Catheter cleared by the FDA?
Epineed Epidural Catheter (K832232) received a 510(k) decision of Substantially Equivalent on August 8, 1983, 28 days after the submission was received.
What is the product code of K832232?
The FDA product code is BSO – Catheter, Conduction, Anesthetic, a Class II (moderate risk) device regulated under 21 CFR 868.5120.