Acessory Pack
FDA 510(k) K923638 · Medtronics Interventional Vascular
510(k) numberK923638
Submission
- Device name
- Acessory Pack
- Applicant
- Medtronics Interventional Vascular
Danvers, MA, US - Received
- July 21, 1992
- Decision date
- February 8, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LIT – Catheter, Angioplasty, Peripheral, Transluminal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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| 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 |
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| K981198 | Medtronic Zuma Guiding CatheterDQY · Traditional | 08/07/1998SE |
| K972944 | Medtronic Mustang Super Floppy Guide Wire/Floppy Guide Wire/Intermediate Guide…DQX · Traditional | 11/03/1997SE |
| K961917 | Medtronic Mustang Steerable Guide Wire (M-45FR, M45FX)DQX · Traditional | 11/20/1996SE |
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| K955651 | Medtronic Sherpa Guiding CatheterDQY · Traditional | 01/22/1996SE |
| K950490 | Medtronic GC IV Coronary Guiding CatheterDQY · Traditional | 11/21/1995SE |
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Questions and answers
When was Acessory Pack cleared by the FDA?
Acessory Pack (K923638) received a 510(k) decision of Substantially Equivalent on February 8, 1993, 202 days after the submission was received.
What is the product code of K923638?
The FDA product code is LIT – Catheter, Angioplasty, Peripheral, Transluminal, a Class II (moderate risk) device regulated under 21 CFR 870.1250.