Epi-Cath(Tm) Epidural Catheter
FDA 510(k) K895204 · Abbott Laboratories
510(k) numberK895204
Submission
- Device name
- Epi-Cath(Tm) Epidural Catheter
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- August 17, 1989
- Decision date
- November 15, 1989
- 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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| 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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Questions and answers
When was Epi-Cath(Tm) Epidural Catheter cleared by the FDA?
Epi-Cath(Tm) Epidural Catheter (K895204) received a 510(k) decision of Substantially Equivalent on November 15, 1989, 90 days after the submission was received.
What is the product code of K895204?
The FDA product code is BSO – Catheter, Conduction, Anesthetic, a Class II (moderate risk) device regulated under 21 CFR 868.5120.