Usci ILLUMEN-8 8F Ptca Guiding Catheter
FDA 510(k) K910154 · C.R. Bard, Inc.
510(k) numberK910154
Submission
- Device name
- Usci ILLUMEN-8 8F Ptca Guiding Catheter
- Applicant
- C.R. Bard, Inc.
Billerica, MA, US - Received
- January 14, 1991
- Decision date
- April 9, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DOY – Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3320
- Specialty
- Clinical Toxicology
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|---|---|---|---|
| K832396 | Central Venous Access Catheter CvacDOY · Traditional | Gish Biomedical, Inc. | 08/31/1983SE |
| K831239 | Walrus Percutaneous Introducer SetDOY · Traditional | Medical Parameters, Inc. | 05/25/1983SE |
| K831191 | Vascular CatheterDOY · Traditional | Medrad, Inc. | 05/09/1983SE |
| K831188 | Connector TubeDOY · Traditional | Medrad, Inc. | 05/09/1983SE |
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Questions and answers
When was Usci ILLUMEN-8 8F Ptca Guiding Catheter cleared by the FDA?
Usci ILLUMEN-8 8F Ptca Guiding Catheter (K910154) received a 510(k) decision of Substantially Equivalent on April 9, 1991, 85 days after the submission was received.
What is the product code of K910154?
The FDA product code is DOY – Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep., a Class II (moderate risk) device regulated under 21 CFR 862.3320.