Scimed 6 Fr., 7 Fr., and 8 Fr.,Triguide Guiding
FDA 510(k) K932420 · Scimed Life Systems, Inc.
510(k) numberK932420
Submission
- Device name
- Scimed 6 Fr., 7 Fr., and 8 Fr.,Triguide Guiding
- Applicant
- Scimed Life Systems, Inc.
Maple Grove, MN, US - Received
- May 19, 1993
- Decision date
- August 17, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
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| K242420 | pNOVUS 21 MicrocatheterDQO · Traditional | Phenox, Ltd. | 11/12/2024SE |
| K233268 | Impress Angiographic CatheterDQO · Special | Merit Medical Systems, Inc. | 05/22/2024SE |
| K233975 | Zoom 6F Insert CathetersDQO · Traditional | Imperative Care, Inc. | 04/02/2024SE |
| K232536 | Soldier MicrocatheterDQO · Traditional | Embolx, Inc. | 02/23/2024SE |
| K232573 | INFINITI Ambi Angiographic CatheterDQO · Traditional | Cordis US Corp | 11/21/2023SE |
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| K974241 | Scimed Informer Pressure Wire SystemDQX · Traditional | 11/12/1998SE |
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| K974559 | Scimed 6 French Impulse Angiographic CathetersDQO · Traditional | 02/23/1998SE |
| K974684 | Scimed 7 French Wiseguide Guide CatheterDQY · Traditional | 02/19/1998SE |
| K973945 | Luge Guide WireDQX · Traditional | 01/12/1998SE |
| K970823 | Scimed 8 French Wiseguide Guide CatheterDQY · Traditional | 06/03/1997SE |
| K964551 | Choice Super Support Ptca Guide Wire, Choice Plus Super Support Ptca Guide Wire, Choice…DQX · Traditional | 05/21/1997SE |
| K970244 | Scimed Choice Family of Ptca Guide WiresDQX · Traditional | 03/28/1997SE |
| K965023 | Choice PT Plus Ptca Guide Wire and Choice PT Vision Ptca Guide WireDQX · Traditional | 03/04/1997SE |
Questions and answers
When was Scimed 6 Fr., 7 Fr., and 8 Fr.,Triguide Guiding cleared by the FDA?
Scimed 6 Fr., 7 Fr., and 8 Fr.,Triguide Guiding (K932420) received a 510(k) decision of Substantially Equivalent on August 17, 1993, 90 days after the submission was received.
What is the product code of K932420?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.