Tri-Lumen Intra Vascular Balloon Catheter
FDA 510(k) K891021 · Ideal Medical, Inc.
510(k) numberK891021
Submission
- Device name
- Tri-Lumen Intra Vascular Balloon Catheter
- Applicant
- Ideal Medical, Inc.
Clearwater, FL, US - Received
- February 28, 1989
- Decision date
- September 18, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXE – Catheter, Embolectomy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5150
- Specialty
- Cardiovascular
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|---|---|---|---|
| K240078 | Fogarty Thru-Lumen Embolectomy CatheterDXE · Traditional | Edwards Lifesciences, LLC | 08/28/2024SE |
| K241330 | Fogarty Fortis Arterial Embolectomy CatheterDXE · Traditional | Edwards Lifesciences | 07/02/2024SE |
| K233820 | Fogarty Arterial Embolectomy Catheter with Gate ValveDXE · Traditional | Edwards Lifesciences | 05/22/2024SE |
| K233819 | Fogarty Venous Thrombectomy CathetersDXE · Traditional | Edwards Lifesciences, LLC | 05/22/2024SE |
| K233619 | Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy CathetersDXE · Traditional | Edwards Lifesciences | 05/20/2024SE |
| K213771 | Merlin Aspiration SystemDXE · Traditional | Mivi Neurovascular, Inc. | 01/27/2022SE |
| K202049 | Python Catheter/Over-the-Wire Latis Graft Cleaning CatheterDXE · Special | Applied Medical Resources Corporation | 09/07/2021SE |
| K193379 | Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon ProbeDXE · Traditional | Edwards Lifesciences, LLC | 06/12/2020SE |
| K163031 | Bunegin-Albin Air Aspiration SetDXE · Traditional | Cook Incorporated | 07/27/2017SE |
| K163353 | Needle's Eye Snare Retrieval Set - 54cmDXE · Special | Cook Incorporated | 07/11/2017SE |
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| K922161 | Grice Soft Tissue Biopsy KitKNW · Traditional | 10/13/1992SE |
| K921922 | Grice Laparoscopic Suturing NeedleGCJ · Traditional | 07/08/1992SE |
| K915175 | Reddick RetractorGAD · Traditional | 04/29/1992SE |
| K914880 | Dual Balloon Embolectomy CatheterDXE · Traditional | 03/16/1992SE |
| K913602 | Ideas' PortFMF · Traditional | 01/02/1992SESK |
| K914913 | Grice Foot Pedal Control/Reddick Irri/Aspir SystGDJ · Traditional | 12/31/1991SE |
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Questions and answers
When was Tri-Lumen Intra Vascular Balloon Catheter cleared by the FDA?
Tri-Lumen Intra Vascular Balloon Catheter (K891021) received a 510(k) decision of Substantially Equivalent on September 18, 1989, 202 days after the submission was received.
What is the product code of K891021?
The FDA product code is DXE – Catheter, Embolectomy, a Class II (moderate risk) device regulated under 21 CFR 870.5150.