Grac High Dose Rate (HDR) Remote Afterloading Catheter
FDA 510(k) K990753 · Cook, Inc.
510(k) numberK990753
Submission
- Device name
- Grac High Dose Rate (HDR) Remote Afterloading Catheter
- Applicant
- Cook, Inc.
Bloomington, IN, US - Received
- March 8, 1999
- Decision date
- May 27, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code JAQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262383 | LumenCare AzureJAQ · Special | Nucletron B.V. | 07/24/2026SE |
| K252717 | MAASTRO Rectal Applicator SetJAQ · Traditional | Varian Medical Systems | 05/20/2026SE |
| K251037 | Rectal ApplicatorJAQ · Traditional | Nucletron B.V. | 12/19/2025SE |
| K252884 | Guided Aarhus Applicator SetJAQ · Traditional | Varian Medical Systems | 11/19/2025SE |
| K250299 | CT/ MR Tandem and Ovoid SetJAQ · Traditional | Varian Medical Systems, Inc. | 05/09/2025SE |
| K250289 | Intracavitary/Interstitial SystemJAQ · Traditional | Varian Medical Systems | 04/25/2025SE |
| K243939 | Titanium Flexible Geometry FSD Applicator Set (GM11013400)JAQ · Traditional | Varian Medical Systems, Inc. | 03/03/2025SE |
| K241764 | Mould Probe MR SafeJAQ · Traditional | Varian Medical Systems, Inc. | 01/10/2025SE |
| K242961 | Intraluminal Applicator SetJAQ · Traditional | Varian Medical Systems | 11/26/2024SE |
| K243045 | BRAXX Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)JAQ · Special | Braxx Biotech Co., Ltd. | 11/19/2024SE |
More from Braxx Biotech Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K233177 | Nest VT Vitrification DeviceMQK · Traditional | 03/08/2024SE |
| K222254 | Gunther Tulip Vena Cava Filter Retrieval SetMMX · Traditional | 05/16/2023SE |
| K223098 | Bakri Essential Postpartum BalloonOQY · Special | 10/28/2022SE |
| K210734 | Endovascular Dilator and SetsDRE · Special | 04/06/2021SE |
| K203670 | Extra Large Check-Flo IntroducerDYB · Traditional | 02/16/2021SE |
| K191498 | Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane…LJE · Traditional | 01/29/2020SESK |
| K190903 | Lawson Retrograde Nephrostomy Wire Puncture SetLJE · Traditional | 12/16/2019SE |
| K193133 | Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi…JOH · Special | 12/12/2019SE |
| K191163 | Lumax Guiding CatheterDQY · Traditional | 12/12/2019SE |
| K190084 | McLean-Ring Enteral Feeding Tube SetKNT · Traditional | 10/11/2019SE |
Questions and answers
When was Grac High Dose Rate (HDR) Remote Afterloading Catheter cleared by the FDA?
Grac High Dose Rate (HDR) Remote Afterloading Catheter (K990753) received a 510(k) decision of Substantially Equivalent on May 27, 1999, 80 days after the submission was received.
What is the product code of K990753?
The FDA product code is JAQ – System, Applicator, Radionuclide, Remote-Controlled, a Class II (moderate risk) device regulated under 21 CFR 892.5700.