Valved Safety Centesis Catheter
FDA 510(k) K150800 · B.Braun Medical, Inc.
510(k) numberK150800
Submission
- Device name
- Valved Safety Centesis Catheter
- Applicant
- B.Braun Medical, Inc.
Allentown, PA, US - Received
- March 26, 2015
- Decision date
- November 12, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GCB – Needle, Catheter
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GCB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974146 | Paracentesis Catheter DeviceGCB · Traditional | Allegiance Healthcare Corp. | 01/28/1998SE |
| K930568 | Adair/Veress Needle Introducer SetGCB · Traditional | Medical Dynamics, Inc. | 07/22/1993SE |
| K923028 | Turkel Pneumothorax KitGCB · Traditional | Symbiosis Corp. | 08/04/1992SE |
| K900374 | Adair/Veress Needle Introducer SetGCB · Traditional | Medical Dynamics, Inc. | 04/20/1990SE |
| K854327 | Subcutaneous Tunneling Needles & HandlesGCB · Traditional | Concord Laboratories, Inc. | 11/13/1985SE |
| K852428 | Manan Epidural NeedleGCB · Traditional | Manan Manufacturing Co., Inc. | 06/27/1985SE |
| K780896 | Needles, Design Change, IV CathetersGCB · Traditional | Jelco Laboratories | 08/23/1978SE |
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| K220756 | Introcan Safety 2 IV CatheterFOZ · Special | 06/23/2022SE |
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Questions and answers
When was Valved Safety Centesis Catheter cleared by the FDA?
Valved Safety Centesis Catheter (K150800) received a 510(k) decision of Substantially Equivalent on November 12, 2015, 231 days after the submission was received.
What is the product code of K150800?
The FDA product code is GCB – Needle, Catheter, a Class I (low risk) device regulated under 21 CFR 878.4200.