Supplemental Tygon Pac-Monitoring Lines
FDA 510(k) K780662 · Norton Performance Plastics Corp.
510(k) numberK780662
Submission
- Device name
- Supplemental Tygon Pac-Monitoring Lines
- Applicant
- Norton Performance Plastics Corp.
Mchenry, IL, US - Received
- April 18, 1978
- Decision date
- June 6, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FMG – Stopcock, I.V. Set
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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| K851299 | Correct FloFPA · Traditional | 05/07/1985SE |
| K842858 | Fluid Administration Line W/Spike 14-923FPA · Traditional | 09/11/1984SE |
| K841828 | Central Venous Catheter W/Big-GardDQY · Traditional | 07/13/1984SE |
| K840240 | Microfuse Intravenous Catheter SetDQY · Traditional | 04/17/1984SE |
| K831587 | Temp. Repair Kit-Dual Lumen CatheterLJS · Traditional | 10/19/1983SE |
| K831698 | Disposable Pressure TRANSDUCER#14004195DRS · Traditional | 08/11/1983SE |
| K830788 | Central Vein Catherization KIT-14-690-DQO · Traditional | 04/30/1983SE |
| K830813 | French Percutaneous Sheath IntroducerDYB · Traditional | 04/28/1983SE |
Questions and answers
When was Supplemental Tygon Pac-Monitoring Lines cleared by the FDA?
Supplemental Tygon Pac-Monitoring Lines (K780662) received a 510(k) decision of Substantially Equivalent on June 6, 1978, 49 days after the submission was received.
What is the product code of K780662?
The FDA product code is FMG – Stopcock, I.V. Set, a Class II (moderate risk) device regulated under 21 CFR 880.5440.