Arrow Pneumothorax Kit, AK-01500
FDA 510(k) K883905 · Arrow Intl., Inc.
510(k) numberK883905
Submission
- Device name
- Arrow Pneumothorax Kit, AK-01500
- Applicant
- Arrow Intl., Inc.
Reading, PA, US - Received
- September 15, 1988
- Decision date
- January 19, 1989
- Decision
- Unknown (SESD)
- Type
- Traditional 510(k)
Device classification
- Product code
- JOL – Catheter And Tip, Suction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6740
- Specialty
- General Hospital
Other 510(k)s with product code JOL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K051370 | Sterile Saline for Device Care, Sterile Water for Device Care, Models 2F7121, 2F8014JOL · Traditional | Baxter Healthcare Corp | 08/12/2005SE |
| K000266 | Primary Care Solutions Sterile SALINE-0.9% Sodium Chloride for Device IrrigationJOL · Traditional | Primary Care Solutions, Inc. | 07/12/2001SE |
| K000265 | Primary Care Solutions Sterile Water Device IrrigationJOL · Traditional | Primary Care Solutions, Inc. | 07/12/2001SE |
| K003402 | Welcon Sterile Water for Device Irrigation; Welcon Sterile 0.9% Normal Saline for Device…JOL · Traditional | Welcon, Inc. | 05/01/2001SE |
| K994321 | Sterile Water and 0.9% Sodium Chloride for Irrigation, UspJOL · Traditional | Automatic Liquid Packaging, Inc. | 10/25/2000SE |
| K974759 | Hydrox Saline Solution 0.9% Sodium Chloride 4 Oz. Cup 120 ML 100 ML BottleJOL · Traditional | Hydrox Laboratories | 03/09/1998SE |
| K974758 | Hydrox Sterile Water 4 Oz. Cup 120 Ml., Hydrox Sterile Water 100 ML BottleJOL · Traditional | Hydrox Laboratories | 03/09/1998SE |
| K974397 | Sterile Saline for Catheter CareJOL · Traditional | Baxter Healthcare Corp | 02/10/1998SE |
| K973734 | Sterile Water for Device Irrigation/ Sterile Saline for Device IrrigationJOL · Traditional | Welcon, Inc. | 02/05/1998SE |
| K972372 | Germ Trapper Suction Tube HolderJOL · Traditional | Rzv Medical Specialties, Inc. | 12/11/1997SE |
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| K100635 | Arrowgard Evolution Antimicrobial Peripherally Inserted Central Catheter (Picc) Model:…LJS · Traditional | 08/27/2010SE |
| K093050 | Arrow Seldinger Arterial Catherization Devices, Models Ex Sac 00520DQY · Special | 12/18/2009SE |
| K071491 | Arrow International, Inc., Surgical DrapesKKX · Traditional | 10/10/2007SE |
| K071998 | Arrow Echogenic Introducer Needle ComponentFMI · Special | 09/26/2007SE |
| K071111 | Non-Absorbable Silk SutureGAP · Traditional | 07/17/2007SE |
| K060309 | Autocat Intra-Aortic Balloon Pump SeriesDSP · Special | 04/06/2006SE |
| K042126 | PiccLJS · Special | 08/27/2004SESU |
| K041153 | Sharpsaway II Locking Disposable CupFMI · Traditional | 07/12/2004SE |
| K040801 | Intra-Aortic Balloon (Iab)DSP · Special | 05/06/2004SE |
| K040802 | Hemosonic 200HEMODYNAMIC MonitorDPN · Special | 04/28/2004SE |
Questions and answers
When was Arrow Pneumothorax Kit, AK-01500 cleared by the FDA?
Arrow Pneumothorax Kit, AK-01500 (K883905) received a 510(k) decision of Unknown on January 19, 1989, 126 days after the submission was received.
What is the product code of K883905?
The FDA product code is JOL – Catheter And Tip, Suction, a Class II (moderate risk) device regulated under 21 CFR 880.6740.