Spring Guide Catheter Anesthesia Conduction Cath
FDA 510(k) K854601 · Concord Laboratories, Inc.
510(k) numberK854601
Submission
- Device name
- Spring Guide Catheter Anesthesia Conduction Cath
- Applicant
- Concord Laboratories, Inc.
Keene, NH, US - Received
- November 18, 1985
- Decision date
- January 10, 1986
- 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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|---|---|---|---|
| K241410 | EDEN ControlCathBSO · Traditional | Jmt Co., Ltd. | 02/13/2025SE |
| K231242 | Perifix FX Catheter; Contiplex FX CatheterBSO · Traditional | B.Braun Medical, Inc. | 09/15/2023SE |
| K230603 | Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen…BSO · Traditional | Teleflex Medical | 08/30/2023SE |
| K193664 | SubQKath Catheter and Needle SetBSO · Traditional | Hk Surgical | 09/09/2020SE |
| K200624 | Percutaneous IntroducerBSO · Traditional | Epimed International, Inc. | 04/27/2020SE |
| K191470 | C-CAT Anaesthesia Catheter kitBSO · Traditional | Cimpax Aps | 10/25/2019SE |
| 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 |
More from B.Braun Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K883840 | Dri-Vent Arterial Blood Sampling KitLKB · Traditional | 05/16/1989SESD |
| K871825 | Meconium Suction CatheterBSY · Traditional | 06/29/1987SE |
| K864535 | Tracheobronchial Suction Catheter, Cat. No. 6110BSY · Traditional | 01/06/1987SE |
| K862039 | Concord Care Tray · Traditional | 07/03/1986SESD |
| K854327 | Subcutaneous Tunneling Needles & HandlesGCB · Traditional | 11/13/1985SE |
| K851134 | Regional Anesthesia TraysCAZ · Traditional | 07/15/1985SESD |
| K842095 | Epidural TraysCAZ · Traditional | 07/03/1984SE |
| K841486 | Arterial Blood Sampling KitsCBT · Traditional | 05/23/1984SE |
| K840987 | Vaporized HeparinCBT · Traditional | 04/05/1984SE |
| K840986 | Prefilled Pulsator SyringeCBT · Traditional | 04/05/1984SE |
Questions and answers
When was Spring Guide Catheter Anesthesia Conduction Cath cleared by the FDA?
Spring Guide Catheter Anesthesia Conduction Cath (K854601) received a 510(k) decision of Substantially Equivalent on January 10, 1986, 53 days after the submission was received.
What is the product code of K854601?
The FDA product code is BSO – Catheter, Conduction, Anesthetic, a Class II (moderate risk) device regulated under 21 CFR 868.5120.