21 CFR 870.1650 — Injector And Syringe, Angiographic
Cardiovascular (CV) · Part 870 Subpart B—Cardiovascular Diagnostic Devices · § 870.1650
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DXT | Injector And Syringe, Angiographic | 2 | 207 | 3rd Party |
| IZQ | Injector, Contrast Medium, Automatic | 2 | 22 | 3rd Party |
| MAV | Syringe, Balloon Inflation | 2 | 57 | 3rd Party |
| NKP | Injector, Contrast Medium, Automatic, Reprocessed | 2 | 0 | 3rd Party |
| NKT | Injector And Syringe, Angiographic, Reprocessed | 2 | 0 | 3rd Party |
| NKU | Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed | 2 | 1 | 3rd Party |
| OEQ | Angiography/Angioplasty Kit | 2 | 0 | |
| OER | Angioscopic Valvulotome Kit | 2 | 0 | |
| OFH | Digital Angiography Tray | 2 | 0 | |
| PTM | Syringe, Balloon Inflation, Exempt | 2 | 0 |
Special Controls
DXT — Injector And Syringe, Angiographic
*Classification.* Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
eCFR
IZQ — Injector, Contrast Medium, Automatic
*Classification.* Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
eCFR
MAV — Syringe, Balloon Inflation
*Classification.* Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
eCFR
NKP — Injector, Contrast Medium, Automatic, Reprocessed
*Classification.* Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
eCFR
NKT — Injector And Syringe, Angiographic, Reprocessed
*Classification.* Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
eCFR
NKU — Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed
*Classification.* Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
eCFR
OEQ — Angiography/Angioplasty Kit
*Classification.* Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
eCFR
OER — Angioscopic Valvulotome Kit
*Classification.* Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
eCFR
OFH — Digital Angiography Tray
*Classification.* Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
eCFR
PTM — Syringe, Balloon Inflation, Exempt
*Classification.* Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
eCFR
