Heart Cath Tray, Sterile, Disposable
FDA 510(k) K981441 · Trinity Laboratories, Inc.
510(k) numberK981441
Submission
- Device name
- Heart Cath Tray, Sterile, Disposable
- Applicant
- Trinity Laboratories, Inc.
Salisbury, MD, US - Received
- April 21, 1998
- Decision date
- July 10, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
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| K233975 | Zoom 6F Insert CathetersDQO · Traditional | Imperative Care, Inc. | 04/02/2024SE |
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| K974238 | Dental Tray, Sterile, DisposableEIA · Traditional | 02/04/1998SE |
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| K972160 | Crp-Lex System: C-Reactive Protein Antigen Detection in Serum: Slide Agglutnation Latex…DCK · Traditional | 08/01/1997SE |
| K970722 | Eye TrayKKX · Traditional | 03/31/1997SE |
| K965201 | O.R. Scrub Prep Tray, Sterile, DisposableLRO · Traditional | 02/14/1997SEKD |
| K964921 | Basic Biopsy Tray. Disposable, SterileLRO · Traditional | 01/22/1997SE |
| K953929 | Mid-Stream Collection Set-SterileLIO · Traditional | 11/16/1995SE |
| K952058 | Sterile V.A.D. (Vascular Access Devices) Access Kit, DisposableFOZ · Traditional | 09/21/1995SE |
| K953070 | Woundfoam 4 X 4KMF · Traditional | 09/08/1995SE |
| K951506 | Suction Catheter Kit, Sterile, Single-UseBSY · Traditional | 07/03/1995SE |
Questions and answers
When was Heart Cath Tray, Sterile, Disposable cleared by the FDA?
Heart Cath Tray, Sterile, Disposable (K981441) received a 510(k) decision of Substantially Equivalent on July 10, 1998, 80 days after the submission was received.
What is the product code of K981441?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.