V-Cath Poly Picc
by Hdc Corp.
510(k) K071875
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK071875 | Date5 Nov 2007 | StatusActive |
Official records
- FDA 510(k) database K071875
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LJS
- Device class
- Class II
- Regulation
- 21 CFR Part 880.5970
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 28 Sep 2026
V-CATH POLY PICC is a catheter, intravascular, therapeutic, long-term greater than 30 days. It is a peripherally inserted central venous catheter made of radiopaque polyurethane tubing with a kink-resistant, reverse-tapered design.
It is used for repeated venous access, infusion, or injection therapy and supports power injection of contrast media up to 5 cc/sec at 300 psi. The device is supplied by Hdc Corp. and has FDA 510(k) clearance under K071875. It is classified as a Class 2 device for general hospital use.
Devices cleared under K071875
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| NeoMagic 3091-1640 | 3091-1640 / 3091-1640 | B339309116400 | Pressure 300 Pound per Square Inch; Length 40 cm; Catheter Gauge 3.0 Fr | On the market |
| Power V-Cath 4091-1660 | 4091-1660 / 4091-1660 | B339409116600 | Pressure 300 Pound per Square Inch; Length 60.0 cm; Catheter Gauge 4.0 Fr | On the market |
| Power V-Cath 4092-1660 | 4092-1660 / 4092-1660 | B339409216600 | Length 60 cm; Catheter Gauge 4.0 Fr | On the market |
| Power V-Cath 5091-2660 | 5091-2660 / 5091-2660 | B339509126600 | Pressure 300 Pound per Square Inch; Length 60.0 cm; Catheter Gauge 5.0 Fr | On the market |
| Power V-Cath 5092-2660 | 5092-2660 / 5092-2660 | B339509226600 | Pressure 300 Pound per Square Inch; Length 60.0 cm; Catheter Gauge 5.0 Fr | On the market |
| PowerStick 30101-1608 | 30101-1608 / 30101-1608 | B3393010116080 | Pressure 300 Pound per Square Inch; Length 8.0 cm; Catheter Gauge 3.0 Fr | On the market |
| PowerStick 30101-1610 | 30101-1610 / 30101-1610 | B3393010116100 | Pressure 300 Pound per Square Inch; Length 10.0 cm; Catheter Gauge 3.0 Fr | On the market |
| PowerStick 30101-1618 | 30101-1618 / 30101-1618 | B3393010116180 | Pressure 300 Pound per Square Inch; Length 18.0 cm; Catheter Gauge 3.0 Fr | On the market |
| PowerStick 30121-1618 | 30121-1618 / 30121-1618 | B3393012116180 | Pressure 300 Pound per Square Inch; Catheter Gauge 3.0 Fr; Length 18.0 cm | On the market |
| PowerStick 40101-1608 | 40101-1608 / 40101-1608 | B3394010116080 | Pressure 300 Pound per Square Inch; Length 8.0 cm; Catheter Gauge 4.0 Fr | On the market |
| PowerStick 40101-1610 | 40101-1610 / 40101-1610 | B3394010116100 | Pressure 300 Pound per Square Inch; Length 10.0 cm; Catheter Gauge 4.0 Fr | On the market |
| PowerStick 40101-1618 | 40101-1618 / 40101-1618 | B3394010116180 | Pressure 300 Pound per Square Inch; Length 18.0 cm; Catheter Gauge 4.0 Fr | On the market |
| PowerStick 40121-1618 | 40121-1618 / 40121-1618 | B3394012116180 | Pressure 300 Pound per Square Inch; Length 18.0 cm; Catheter Gauge 4.0 Fr | On the market |
Similar devices
Other devices filed under FDA product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days).
- ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM) by Luther Medical Products, Inc.
- 6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET by Medical Components, Inc.
- NMI PICC III and NMI PICC IV by NAVILYST MEDICAL, INC.
- NMI IC by NAVILYST MEDICAL, INC.
- HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); Hydr by ACCESS VASCULAR, INC
- STRATO/INFUSAID TUNNELER by Strato/Infusaid, Inc.
- NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER by Marvao Medical Devices, Ltd.
- POWERHOHN AND POWERLINE CATHETERS by C. R. Bard, Inc.
- PERIPHERALLY INSERTED CENTRAL CATHETER by Utah Medical Products, Inc.
- BD L-CATH SINGLE AND DUAL LUMENT CATHETERS, MIDLINE CATHETER by BECTON, DICKINSON & CO.