Angiocath & Insyte Autoguard Catheters
FDA 510(k) K952861 · Becton Dickinson Vascular Access, Inc.
510(k) numberK952861
Submission
- Device name
- Angiocath & Insyte Autoguard Catheters
- Applicant
- Becton Dickinson Vascular Access, Inc.
Sandy, UT, US - Received
- June 22, 1995
- Decision date
- July 31, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FOZ – Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5200
- Specialty
- General Hospital
Other 510(k)s with product code FOZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260432 | Ruby Intravascular CatheterFOZ · Traditional | Venocare, Inc. | 09/02/2026SE |
| K260165 | Unimpregnated Central Venous CatheterFOZ · Traditional | Spectrum Vascular | 08/10/2026SE |
| K261041 | ClearSafe Closed SystemFOZ · Traditional | MedSource Labs, LLC | 07/10/2026SE |
| K260539 | MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV CatheterFOZ · Traditional | MedSource Labs, LLC | 07/09/2026SE |
| K253235 | Introcan Safety® Deep Access XL IV CatheterFOZ · Traditional | B.Braun Medical, Inc. | 05/15/2026SE |
| K252137 | BD Insyte IV CatheterFOZ · Traditional | Becton Dickinson Infusion Therapy Systems, Inc. | 04/02/2026SE |
| K252513 | Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm…FOZ · Special | Poly Medicure Limited | 04/01/2026SE |
| K252398 | SURFLO Hybria Closed System Safety IV CatheterFOZ · Traditional | Terumo Medical Products (Hangzhou) Co., Ltd. | 12/17/2025SE |
| K252677 | Polyshield Safety IV CathetersFOZ · Special | Poly Medicure Limited | 11/05/2025SE |
| K251422 | BD Saf-T-Intima Subcutaneous Catheter SystemFOZ · Traditional | Becton Dickinson Infusion Therapy Systems, Inc. | 10/08/2025SE |
More from Becton Dickinson Infusion Therapy Systems, Inc.
| 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 |
| K954906 | First Picc Introducer CatheterDYB · Traditional | 04/08/1996SE |
| 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 Angiocath & Insyte Autoguard Catheters cleared by the FDA?
Angiocath & Insyte Autoguard Catheters (K952861) received a 510(k) decision of Substantially Equivalent on July 31, 1995, 39 days after the submission was received.
What is the product code of K952861?
The FDA product code is FOZ – Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, a Class II (moderate risk) device regulated under 21 CFR 880.5200.