Pad, B-D I.V. Cath.
FDA 510(k) K781854 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK781854
Submission
- Device name
- Pad, B-D I.V. Cath.
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Washington, DC, US - Received
- November 6, 1978
- Decision date
- December 4, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KGZ – Accessories, Catheter
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
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| K893406 | Deseret PRN AdapterKGZ · Traditional | Deseret Medical, Inc. | 06/22/1989SE |
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| K002938 | B-D Ultra-Fine III Pen Needle; Model 31G X 3/16FMI · Traditional | 11/29/2000SE |
| K001364 | BD Directigen Flu A+BPSZ · Traditional | 06/28/2000SE |
| K000762 | Moxifloxacin, 5 Ug, BBL Sensi-DiscJTN · Traditional | 04/25/2000SE |
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| K993186 | Synercid, 15 Ug, BBL Sensi-DiscJTN · Traditional | 11/03/1999SE |
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Questions and answers
When was Pad, B-D I.V. Cath. cleared by the FDA?
Pad, B-D I.V. Cath. (K781854) received a 510(k) decision of Substantially Equivalent on December 4, 1978, 28 days after the submission was received.
What is the product code of K781854?
The FDA product code is KGZ – Accessories, Catheter, a Class I (low risk) device regulated under 21 CFR 878.4200.