GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER
FDA 510(k) clearance K990753 · decided 1999-05-27
Clearance details
- K-number
- K990753
- Device name
- GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER
- Applicant
- Cook, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-03-08
- Decision date
- 1999-05-27
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- JAQ
- Device class
- 2
- Regulation number
- 892.5700
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Bloomington, IN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cook
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LumenCare Azure (K262383) | Nucletron B.V. | 2026-07-24 |
| MAASTRO Rectal Applicator Set (K252717) | Varian Medical Systems | 2026-05-20 |
| Rectal Applicator (K251037) | Nucletron B.V. | 2025-12-19 |
| Guided Aarhus Applicator Set (K252884) | Varian Medical Systems | 2025-11-19 |
| CT/ MR Tandem and Ovoid Set (K250299) | Varian Medical Systems, Inc. | 2025-05-09 |
| Intracavitary/Interstitial System (K250289) | Varian Medical Systems | 2025-04-25 |
| Titanium Flexible Geometry FSD Applicator Set (GM11013400) (K243939) | Varian Medical Systems, Inc. | 2025-03-03 |
| Mould Probe MR Safe (K241764) | Varian Medical Systems, Inc. | 2025-01-10 |
| Intraluminal Applicator Set (K242961) | Varian Medical Systems | 2024-11-26 |
| “BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002) (K243045) | Braxx Biotech Co., Ltd. | 2024-11-19 |
| Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve (K241853) | Varian Medical Systems, Inc. | 2024-11-07 |
| Catheter Surface Flap Applicator Set (GM11011830) (K241965) | Varian Medical Systems | 2024-10-29 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Zenith® Iliac Branch (P020018/S064) | Cook, Inc. | 2025-05-30 |
| ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEM (P020018/S065) | Cook, Inc. | 2025-04-09 |
| Zenith Fenestrated AAA Endovascular Graft (P020018/S063) | Cook, Inc. | 2024-04-29 |
| Zenith® Fenestrated AAA Endovascular Graft, Zenith® Flex AAA Endovascular System (P020018/S061) | Cook, Inc. | 2023-12-14 |
| Zenith® Fenestrated AAA Endovascular Graft (ZFEN), Zenith® Flex AAA Endovascular System (P020018/S062) | Cook, Inc. | 2023-12-13 |
| Zenith Fenestrated AAA Endovascular Graft (P020018/S060) | Cook, Inc. | 2022-01-20 |
| Zenith AAA Endovascular Graft (P020018/S059) | Cook, Inc. | 2020-10-08 |
| ZENITH FLEX AAA ENDOVASCULAR GRAFT (P020018/S055) | Cook, Inc. | 2018-10-10 |