Pneumothorax Kit, Modification
FDA 510(k) K904021 · Arrow Intl., Inc.
510(k) numberK904021
Submission
- Device name
- Pneumothorax Kit, Modification
- Applicant
- Arrow Intl., Inc.
Reading, PA, US - Received
- August 29, 1990
- Decision date
- October 9, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JDC – Prosthesis, Elbow, Constrained, Cemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3150
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JDC
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|---|---|---|---|
| K181362 | TEMA Elbow SystemJDC · Traditional | Lima Corporate S.P.A. | 02/16/2019SE |
| K181307 | Zimmer Nexel Total Elbow, Connrad/Morrey Total ElbowJDC · Traditional | Zimmer, Inc. | 01/28/2019SE |
| K153398 | Comprehensive SRS/Nexel ElbowJDC · Traditional | Biomet Manufacturing Corp | 02/03/2016SE |
| K150501 | Zimmer Nexel Total Elbow Ulnar Cement DiverterJDC · Traditional | Zimmer, Inc. | 04/23/2015SE |
| K123862 | Zimmer Nexel Total ElbowJDC · Traditional | Zimmer, Inc. | 03/12/2013SE |
| K090473 | Discovery Elbow - X-SmallJDC · Special | Biomet Manufacturing Corp | 03/25/2009SE |
| K060696 | Acclaim Total Elbow SystemJDC · Special | DePuy Orthopaedics, Inc. | 04/14/2006SE |
| K053189 | Coonrad/Morrey Total Elbow, Model 8105 SeriesJDC · Special | Zimmer, Inc. | 12/09/2005SE |
| K051975 | Porous Coated Discovery ElbowJDC · Special | Biomet, Inc. | 09/06/2005SE |
| K042664 | LPS Upper ExtremityJDC · Traditional | Depuy, Inc. | 12/08/2004SE |
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| 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 Pneumothorax Kit, Modification cleared by the FDA?
Pneumothorax Kit, Modification (K904021) received a 510(k) decision of Substantially Equivalent on October 9, 1990, 41 days after the submission was received.
What is the product code of K904021?
The FDA product code is JDC – Prosthesis, Elbow, Constrained, Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3150.