Usci Super 9 Ptca Guiding Catheter
FDA 510(k) K922541 · C.R. Bard, Inc.
510(k) numberK922541
Submission
- Device name
- Usci Super 9 Ptca Guiding Catheter
- Applicant
- C.R. Bard, Inc.
Billerica, MA, US - Received
- May 29, 1992
- Decision date
- December 8, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQI – Withdrawal/Infusion Pump
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1800
- Specialty
- Cardiovascular
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| K905189 | Baxter Angioscopy Pump Tubing Set (Model NL)DQI · Traditional | Baxter Healthcare Corp | 01/30/1991SE |
| K902444 | Clearview(Tm) Angioscopic Irrigation PumpDQI · Traditional | Intramed Laboratories, Inc. | 08/30/1990SE |
| K895688 | Nobles-Lai Engineering Infusion PumpDQI · Traditional | Nobles-Lai Engineering, Inc. | 02/26/1990SE |
| K895074 | Angioscopy PumpDQI · Traditional | Baxter Healthcare Corp | 01/31/1990SE |
| K871422 | Olympus Angioscopy PumpDQI · Traditional | Olympus Corp. | 08/12/1987SE |
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Questions and answers
When was Usci Super 9 Ptca Guiding Catheter cleared by the FDA?
Usci Super 9 Ptca Guiding Catheter (K922541) received a 510(k) decision of Substantially Equivalent on December 8, 1992, 193 days after the submission was received.
What is the product code of K922541?
The FDA product code is DQI – Withdrawal/Infusion Pump, a Class II (moderate risk) device regulated under 21 CFR 870.1800.