21 CFR 870.3375 — Filter, Intravascular, Cardiovascular
Cardiovascular (CV) · Part 870 Subpart D—Cardiovascular Prosthetic Devices · § 870.3375
Identification
A cardiovascular intravascular filter is an implant that is placed in the inferior vena cava for the purpose of preventing pulmonary thromboemboli (blood clots generated in the lower limbs and broken loose into the blood stream) from flowing into the right side of the heart and the pulmonary circulation.
Classification Rationale
Class II. The special controls for this device are:
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DTK | Filter, Intravascular, Cardiovascular | 2 | 84 | Implant |
| PNS | Short-Term Intravascular Filter Catheter | 2 | 1 | Implant |
Special Controls
DTK — Filter, Intravascular, Cardiovascular
*Classification.* Class II. The special controls for this device are:(1) “Use of International Standards Organization's ISO 10993 ‘Biological Evaluation of Medical Devices Part I: Evaluation and Testing,’ ” and (2) FDA's: (i) “510(k) Sterility Review Guidance and Revision of 2/12/90 (K90-1)” and (ii) “Guidance for Cardiovascular Intravascular Filter 510(k) Submissions.”
eCFR
DTK — Filter, Intravascular, Cardiovascular
(1) “Use of International Standards Organization's ISO 10993 ‘Biological Evaluation of Medical Devices Part I: Evaluation and Testing,’ ” and (2) FDA's: (i) “510(k) Sterility Review Guidance and Revision of 2/12/90 (K90-1)” and (ii) “Guidance for Cardiovascular Intravascular Filter 510(k) Submissions.”
Ecfr Llm
PNS — Short-Term Intravascular Filter Catheter
*Classification.* Class II. The special controls for this device are:(1) “Use of International Standards Organization's ISO 10993 ‘Biological Evaluation of Medical Devices Part I: Evaluation and Testing,’ ” and (2) FDA's: (i) “510(k) Sterility Review Guidance and Revision of 2/12/90 (K90-1)” and (ii) “Guidance for Cardiovascular Intravascular Filter 510(k) Submissions.”
eCFR
