First Picc Introducer Catheter
FDA 510(k) K954906 · Becton Dickinson Vascular Access, Inc.
510(k) numberK954906
Submission
- Device name
- First Picc Introducer Catheter
- Applicant
- Becton Dickinson Vascular Access, Inc.
Sandy, UT, US - Received
- October 25, 1995
- Decision date
- April 8, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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| K261242 | SimplGuideDYB · Traditional | Pendracare | 06/25/2026SE |
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| K261492 | FieldFlex Steerable SheathDYB · Special | CenterPoint Systems, LLC | 06/05/2026SE |
| K260606 | Echo Large Bore Introducer SheathDYB · Traditional | Echo Medical, LLC | 04/29/2026SE |
| K254248 | Introducer Sheath SetDYB · Traditional | Cardiocycle Medical(Suzhou) Co., Ltd. | 04/23/2026SE |
| K254279 | Edwards eSheath+ introducer setDYB · Traditional | Edwards Lifesciences | 04/17/2026SE |
| K260091 | Aventus Introducer SheathDYB · Traditional | Inquis Medical | 04/13/2026SE |
| K260839 | Protaryx Transseptal Puncture Device (PTX2-001)DYB · Traditional | Protaryx Medical, Inc. | 04/10/2026SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K971339 | Insyte, Insyte-W, Insyte Autoguard CathetersFOZ · Traditional | 12/24/1997SE |
| K970259 | E-Z Set Infusion Set/Saf-T E-Z Set Infusion SetFPA · Traditional | 04/08/1997SE |
| K964050 | First Midcath CatheterFOZ · Traditional | 01/06/1997SE |
| K964049 | First Midcath Catheter with Dual LumensFOZ · Traditional | 01/06/1997SE |
| K964048 | First Midcath Catheter KitFOZ · Traditional | 01/06/1997SE |
| K952861 | Angiocath & Insyte Autoguard CathetersFOZ · Traditional | 07/31/1995SE |
| K952757 | Angiocath, Novbalon, Angio-Set Intravascular & Angiocath Introduction Drainage CatheterFOZ · Traditional | 07/31/1995SE |
| K952053 | E-Z Set, Saf-T E-Z Set, and Minicath Infusion SetsFPA · Traditional | 05/31/1995SE |
| K950301 | Angiocath(R) Nonvalon(R) and Angio-Set(R) IV CathetersFOZ · Traditional | 04/18/1995SE |
| K950438 | Safedweel Dressing Change TrayFRG · Traditional | 03/15/1995SESK |
Questions and answers
When was First Picc Introducer Catheter cleared by the FDA?
First Picc Introducer Catheter (K954906) received a 510(k) decision of Substantially Equivalent on April 8, 1996, 166 days after the submission was received.
What is the product code of K954906?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.