Tri-Lumen Intra Vascular Balloon Catheter (Gu Use)
FDA 510(k) K891588 · Ideal Medical, Inc.
510(k) numberK891588
Submission
- Device name
- Tri-Lumen Intra Vascular Balloon Catheter (Gu Use)
- Applicant
- Ideal Medical, Inc.
Clearwater, FL, US - Received
- March 17, 1989
- Decision date
- September 28, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LQR – Dislodger, Stone, Biliary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5010
- Specialty
- Gastroenterology, Urology
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|---|---|---|---|
| K253056 | Disposable Stone Extraction BasketLQR · Traditional | Zhejiang Soudon Medical Technology Co., Ltd. | 04/03/2026SE |
| K243807 | Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432PLQR · Traditional | Olympus Medical Systems Corp. | 03/18/2025SE |
| K243471 | Extraction BasketLQR · Traditional | Micro-Tech (Nanjing) Co., Ltd. | 12/16/2024SE |
| K240192 | Single-use Extraction BasketsLQR · Traditional | Scivita Medical Technology Co., Ltd. | 10/15/2024SE |
| K230598 | Stone Extraction BasketsLQR · Traditional | Jiangsu Vedkang Medical Science and Technology… | 09/12/2023SE |
| K203322 | SpyGlass Discover Retrieval BasketLQR · Traditional | Boston Scientific Corporation | 05/26/2021SE |
| K201509 | Disposable Stone Extraction basketLQR · Traditional | Hangzhou AGS MedTech Co., Ltd. | 12/16/2020SE |
| K191789 | Stonetome Stone Removal DeviceLQR · Special | Boston Scientific Corporation | 07/25/2019SESK |
| K182381 | Wilson-Cook Mini BasketLQR · Traditional | Wilson-Cook Medical, Inc. | 10/30/2018SE |
| K171969 | Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5…LQR · Traditional | Wilson-Cook Medical, Inc. | 03/28/2018SE |
More from Wilson-Cook Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K944067 | Peanut Wand, ModificationGCS · Traditional | 12/08/1994SE |
| K931115 | Hatcher Stone-Embolis ExtractorLQR · Traditional | 08/20/1993SE |
| K926335 | Ideas Peanut WandGCJ · Traditional | 06/24/1993SE |
| 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 |
| K912540 | Contour-PortLJT · Traditional | 08/23/1991SESK |
Questions and answers
When was Tri-Lumen Intra Vascular Balloon Catheter (Gu Use) cleared by the FDA?
Tri-Lumen Intra Vascular Balloon Catheter (Gu Use) (K891588) received a 510(k) decision of Substantially Equivalent on September 28, 1989, 195 days after the submission was received.
What is the product code of K891588?
The FDA product code is LQR – Dislodger, Stone, Biliary, a Class II (moderate risk) device regulated under 21 CFR 876.5010.