Usci Ideal Ptca Kit
FDA 510(k) K953522 · Ryder Intl. Corp.
510(k) numberK953522
Submission
- Device name
- Usci Ideal Ptca Kit
- Applicant
- Ryder Intl. Corp.
Brunswick, NJ, US - Received
- July 27, 1995
- Decision date
- April 17, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAV – Syringe, Balloon Inflation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1650
- Specialty
- Cardiovascular
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| K881981 | Assist(Tm) Aseptic Syringe Irrigation SystemKOD · Traditional | 08/02/1988SE |
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| K853727 | Kestrel Contact Lens Storage Case(Polysulfone)LRX · Traditional | 02/07/1986SE |
| K853729 | Kestrel Contact Lens Storage Case(Polystyrene)HPX · Traditional | 12/13/1985SE |
| K853728 | Kestrel Contact Lens Storage Case(Noryl)HPX · Traditional | 12/13/1985SE |
Questions and answers
When was Usci Ideal Ptca Kit cleared by the FDA?
Usci Ideal Ptca Kit (K953522) received a 510(k) decision of Substantially Equivalent on April 17, 1996, 265 days after the submission was received.
What is the product code of K953522?
The FDA product code is MAV – Syringe, Balloon Inflation, a Class II (moderate risk) device regulated under 21 CFR 870.1650.