Thoracic Cathter Stylet
FDA 510(k) K913539 · Intl. Medical Devices , Ltd.
510(k) numberK913539
Submission
- Device name
- Thoracic Cathter Stylet
- Applicant
- Intl. Medical Devices , Ltd.
Los Angeles, CA, US - Received
- August 9, 1991
- Decision date
- January 21, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GBX – Catheter, Irrigation
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
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| K052286 | Deutsch Anti-Blockage Wound DrainGBX · Traditional | The Catheter Exchange, Inc. | 10/21/2005SE |
| K043515 | GraftsaverGBX · Traditional | Vescare, Inc. | 03/31/2005SE |
| K013417 | Misonix Irrigation System Moedl BC20PGBX · Traditional | Misonix, Inc. | 01/10/2002SE |
| K000704 | DMC Saphenous Vein Distention System (SVDS)GBX · Traditional | Dmc Medical, Ltd. | 05/19/2000SE |
| K974233 | Lysonix Irrigation SystemGBX · Traditional | Lysonix, Inc. | 02/03/1998SE |
| K973703 | Jackson-Pratt Hemaduct Wound Drain, Jackson-Pratt Gold Hemaduct Wound DrainGBX · Traditional | Allegiance Healthcare Corp. | 12/04/1997SE |
| K972635 | Ultracell Suction SpongeGBX · Traditional | Ultracell Medical Technologies, Inc. | 10/01/1997SE |
| K965146 | Flat Closed Wound Drain with TrocarGBX · Traditional | Axiom Medical, Inc. | 03/10/1997SE |
More from Axiom Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K913541 | Neo-Thor Thoracostomy KitFMF · Traditional | 04/09/1992SE |
| K913540 | Pedia-Thor Thoracostomy KitFMF · Traditional | 04/09/1992SE |
| K913542 | Thoracic Catheter with GuideGBX · Traditional | 01/21/1992SE |
| K913543 | Thoracic Catheter StyletDRB · Traditional | 10/04/1991SE |
| K862909 | Re-Trake Weiss Emergency Airway & Thoracic SystemBTO · Traditional | 09/09/1986SE |
| K850398 | Nu-Cath Emergency KitFOZ · Traditional | 03/27/1985SE |
| K843785 | Wisss Pediatric Trach- Tube W/ObturatorBTO · Traditional | 10/23/1984SE |
| K842666 | Nu-Thor Thoracostomy KitKGZ · Traditional | 09/20/1984SE |
| K840925 | Pedia-Trake Cricothyrotomy KitBTO · Traditional | 05/02/1984SE |
| K820778 | Respiration Monitor 1000BZQ · Traditional | 05/03/1982SE |
Questions and answers
When was Thoracic Cathter Stylet cleared by the FDA?
Thoracic Cathter Stylet (K913539) received a 510(k) decision of Substantially Equivalent on January 21, 1992, 165 days after the submission was received.
What is the product code of K913539?
The FDA product code is GBX – Catheter, Irrigation, a Class I (low risk) device regulated under 21 CFR 878.4200.