Stealth Dilation Catheter System
FDA 510(k) K893411 · Target Therapeutics
510(k) numberK893411
Submission
- Device name
- Stealth Dilation Catheter System
- Applicant
- Target Therapeutics
San Jose, CA, US - Received
- May 2, 1989
- Decision date
- September 5, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LIT – Catheter, Angioplasty, Peripheral, Transluminal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
Other 510(k)s with product code LIT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260304 | WAVE PTA Balloon CatheterLIT · Traditional | WAVE Medical AG | 05/20/2026SE |
| K252512 | Armada 14 NC PTA CatheterLIT · Traditional | Abbott Medical | 02/13/2026SE |
| K251915 | Amethyst HP PTA OTW 0.035 CatheterLIT · Traditional | Natec Medical , Ltd. | 12/18/2025SE |
| K250706 | Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters…LIT · Special | Biotronik, Inc. | 04/04/2025SE |
| K243704 | Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon…LIT · Traditional | Brosmed Medical Co., Ltd. | 02/27/2025SE |
| K241040 | Amethyst HP PTA OTW 0.035 CatheterLIT · Traditional | Natec Medical , Ltd. | 12/18/2024SE |
| K242419 | 018 Hydrophilic Coated OTW PTA Balloon Dilatation CatheterLIT · Traditional | Creagh Medical Ltd. Dba Surmodics, Inc. | 11/15/2024SE |
| K241740 | Finesse Injectable PTA Balloon Dilatation CatheterLIT · Special | Summa Therapeutics | 07/16/2024SE |
| K241711 | Oscar Peripheral Multifunctional Catheter systemLIT · Special | Biotronik, Inc. | 07/11/2024SE |
| K241683 | Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling…LIT · Special | Boston Scientific Corporation | 07/10/2024SE |
More from Boston Scientific Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K965071 | Detachable Slicone Balloon (DSB)MZQ · Traditional | 04/21/1998SE |
| K964488 | Detachable Silicone Balloon (DSB)MZQ · Traditional | 04/21/1998SE |
| K964210 | Retriever IIDQO · Traditional | 10/31/1997SE |
| K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid…DQX · Traditional | 07/14/1997SE |
| K965189 | SpinnakerKRA · Traditional | 03/24/1997SE |
| K964112 | Berenstein CoilKRD · Traditional | 02/26/1997SE |
| K963307 | GDC Patient Return Electtrode Model 45021HCG · Traditional | 12/17/1996SE |
| K962503 | Guglielmi Detachable CoilHCG · Traditional | 09/20/1996SE |
| K961923 | Berenstein CoilHCG · Traditional | 08/15/1996SE |
| K960705 | Guglielmi Detachable CoilHCG · Traditional | 05/21/1996SE |
Questions and answers
When was Stealth Dilation Catheter System cleared by the FDA?
Stealth Dilation Catheter System (K893411) received a 510(k) decision of Substantially Equivalent on September 5, 1989, 126 days after the submission was received.
What is the product code of K893411?
The FDA product code is LIT – Catheter, Angioplasty, Peripheral, Transluminal, a Class II (moderate risk) device regulated under 21 CFR 870.1250.