Multi-Track Angiographic Catheter (K952984, K003902) - Recommended for use in Multi-Track Anglography of cardiovascular vessels and/or chambers. It can be used for catheterization for anglogiap. In and pressure measurement in any chamber or vessel. Ghost II PTA (K003972, K011557) - This catheter is recommended for Percutaneous Gransbuminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries. Z-MED Catheter (K991977, K003114, K003643, K011557) - This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve. - A patient with isolated pulmonary stenosis . - A patient with valvular pulmonary stenosis with other minor congenital heart disease that 사 does not require surgical intervention. And; (K931009, K011557) This catheter is recommended for Percutaneous Transluminal Angioplasty (ISSIN67) Internoral, ilias, and renal arteries. These catheters are not designed to be used in the coronary arteries. Tyshak Mini Pediatric PTV Catheter (K003276, K011557, K032591) - This catheter is I your recuration for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve in Pediatric applications. - A patient with isolated pulmonary stenosis. u - A patient with valvular pulmonary stenosis with other minor congenital heart disease that l does not require surgical intervention. Tyshak Catheter (K991977, K003114, K011557) - This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve. - A patient with isolated pulmonary stenosis u - A patient with valvular pulmonary stenosis with other minor congenital heart disease that ■ does not require surgical intervention. And; (K931009, K011557) This catheter is recommended for Percutaneous Transluminal Angioplasty (RSS1007, Norths of I'ms cancenal arteries. These catheters are not designed to be used in the coronary arteries. Tyshak II Catheter (K003052, K011557, K030589) - This catheter is recommended for I Yshak II Catherer in Catherer (PTV) of the pulmonary valve. - A patient with isolated pulmonary stenosis i - A patient with isolated pulmonary stenosis A patient with valvular pulmonary stenosis with other minor congenital heart disease that I does not require surgical intervention. And; Z-MED II Catheter (K003052, K011557, K030589) - This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve. - A patient with isolated pulmonary stenosis . - A patient with isolated pulmonary stenosis with other minor congenital heart disease that l does not require surgical intervention. And; High Pressure PTA (Marauder) (K010880, K011557) - This catheter is recommended for right Fressure I 17x (maraduct) (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries. Z-5 Atrioseptostomy (K960070, K011557) - Used for the palliation of several congenital heart 2-5 All loseptosition of the great arteries, total anomalous pulmonary venous drainage without delects. transposition of the Ereal arcess, mitral stenosis, mitral atresia, and pulmonary atresia with intact ventricular septum. Z-5 Braided Atrioseptostomy (K001804, K011557) - Used for the palliation of several 2-3 Draided Attrioseptostom. (2001 of the great arteries, total anomalous pulmonary venous congential licar delected transportion, tricuspid atresia, mitral stenosis, mitral atressa, and pulmonary atresia with intact ventricular septum. Tyshak X Catheter (K022722) - This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve. - A patient with isolated pulmonary stenosis . - A patient with valvular pulmonary stenosis with other minor congenital heart disease that I does not require surgical intervention. Tyshak II X Catheter (K022722) - This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve. - A patient with isolated pulmonary stenosis . - A patient with valvular pulmonary stenosis with other minor congenital heart disease that 1 does not require surgical intervention. Z-MED X Catheter (K022722) - This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve. - A patient with isolated pulmonary stenosis a - A patient with valvular pulmonary stenosis with other minor congenital heart disease that . does not require surgical intervention. Z ·MED II X Catheter (K022722) - This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve. - A patient with isolated pulmonary stenosis . - A patient with valvular pulmonary stenosis with other minor congenital heart disease that . does not require surgical intervention. COEfficient Catheter (K014124) - This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve. - A patient with isolated pulmonary stenosis ﺎ - A patient with isolated pulmonary stenosis with other minor congenital heart disease that I does not require surgical intervention. Ghost PTA (K931009, K011557) - This catheter is recommended for Percutaneous Gross ITTA (KSJ1007) RW115872 - The femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries. Mullins PTA (K013601) - This catheter is recommended for Percutaneous Transluminal Millins ITA (INVL001) - This Satileter and renal arteries. These catheters are not designed to be used in the coronary arteries. Mullins X PTA (K022722)_- This catheter is recommended for Percutaneous Transluminal Mullins A F FA (XN22122) - Frid Sains and renal arteries. These catheters are not designed to be used in the coronary arteries. PTS (K003320, K011557) - For use in those patients with cardiovascular defects wherein accurate measurement of the defect is important to select the appropriately sized occluder device.
Device Story
NuMED catheters are intravascular devices used for diagnostic angiography, pressure measurement, angioplasty (PTA), valvuloplasty (PTV), atrioseptostomy, and defect sizing. Operated by physicians in clinical settings; catheters are inserted into vessels/chambers to perform procedures or measurements. Output is visual/hemodynamic data or mechanical dilation/septostomy. This submission extends shelf life from 3 to 5 years based on validation testing. No changes to materials or design.
Clinical Evidence
Bench testing only. Validation testing performed to support the extension of shelf life from 3 to 5 years.
Technological Characteristics
Intravascular catheters for diagnostic and interventional use. Materials and design remain unchanged from previously cleared versions. Shelf life validated to 5 years.
Indications for Use
Indicated for cardiovascular vessel/chamber angiography, pressure measurement, percutaneous transluminal angioplasty (PTA) of femoral/iliac/renal arteries, percutaneous transluminal valvuloplasty (PTV) of pulmonary valve (isolated stenosis or minor congenital heart disease), atrioseptostomy for congenital heart defects (e.g., transposition of great arteries, mitral/tricuspid/pulmonary atresia), and sizing of cardiovascular defects for occluder selection. Contraindicated for coronary artery use.
Regulatory Classification
Identification
An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.
{0}------------------------------------------------
## SUMMARY OF SAFETY AND EFFECTIVENESS DATA
May 12, 2004
Submitted By: NuMED, Inc. , 2880 Main St., Hopkinton, NY 12965 (Ph) 315-328-4491 (F) 315-328-4941
Contact Person: Nichelle LaFlesh
Device Name: All NuMED Catheters
Predicate Devices: All NuMED Catheters
None of the materials have changed in any of these products, since Biocompatibility Testing : the most current approval from the FDA.
Comparison Information: The current shelf life validation is for three years. Through the new validation and testing, NuMED would like to extend the shelf life to 5 years.
K003902 - Multi-Track Angiographic Catheter K003972 - Ghost II PTA Catheter K003643 - Z-MED Catheter K003276 - Tyshak Mini Pediatric Catheter K003114 - Tyshak and Z-MED Catheters K003052 – Tyshak II and Z-MED II Catheters K991977 - Tyshak and Z-MED PTV Catheters K001804 - Z-5 Atrioseptostomy Catheters K960070 - Z-5 Atrioseptostomy Catheters K931009 - Tyshak, Z-MED, and Ghost PTA Catheters K010880 - High Pressure Catheter (Marauder) K952984 - Multi-Track Angiographic Catheter K030589 – Tyshak II and Z-MED II Catheters K032591 - Tyshak Mini Pediatric Catheter K014124 - COEfficient PTV Catheter K003320 - PTS Sizing Balloon Catheter K013601 - Mullins PTA Catheter K011557 - 'Y' Change Submission K022722 - X line of Catheters (Tyshak X, Tyshak II X, Z-MED X, Z-MED II X, and Mullins X)
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services (HHS) in the USA. The seal features the HHS logo, which is a stylized human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 28 2009
Ms. Nichelle LaFlesh Regulatory Affairs Manager NuMED, Inc. 2880 Main St. Hopkinton, NY 12965
K040830 Re: All NuMED Catheters Regulation Number: 21 CFR 870.1200, 870.1250, 870.4450, and 870.5175 Regulation Name: Diagnostic Intravascular Catheter, Percutaneous Catheter, Vascular Clamp, Setostomy Catheter Regulatory Class: Class II Product Code: DQO, LIT, OMZ, DQY, MJN and DXF Dated: June 2, 2004 Received: June 3, 2004
Dear Ms. LaFlesh:
This letter corrects our substantially equivalent letter of June 18, 2004.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act
{2}------------------------------------------------
## Page 2 - Ms. Nichelle LaFlesh
or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Dma R.V. lines
Bram D. Zuckerman, M.D. Director, Division of Cardiovascular Devices Office of Device Eyaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
## Indications For Use
510(k) Number (if known): K040830
Device Names: Multi-Track Angiographic, Ghost II PTA, Ghost PTA, Z-MED, Z-MED II, Z-DCVICC Names: Multi Track Angelay - Tyshak II, Tyshak II X, Tyshak Mini Pediatric PTV, MED X, Z-MLD II A, 15thaid Atrioseptostomy, High Pressure PTA (Marauder), PTS, Mullins, Mullins X, and COEfficient.
Indications For Use:
Multi-Track Angiographic Catheter (K952984, K003902) - Recommended for use in Multi-Track Anglography of cardiovascular vessels and/or chambers. It can be used for catheterization for anglogiap. In and pressure measurement in any chamber or vessel.
Ghost II PTA (K003972, K011557) - This catheter is recommended for Percutaneous Gransbuminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.
Z-MED Catheter (K991977, K003114, K003643, K011557) - This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.
- A patient with isolated pulmonary stenosis .
- A patient with valvular pulmonary stenosis with other minor congenital heart disease that 사 does not require surgical intervention. And;
(K931009, K011557) This catheter is recommended for Percutaneous Transluminal Angioplasty (ISSIN67) Internoral, ilias, and renal arteries. These catheters are not designed to be used in the coronary arteries.
Tyshak Mini Pediatric PTV Catheter (K003276, K011557, K032591) - This catheter is I your recuration for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve in Pediatric applications.
- A patient with isolated pulmonary stenosis. u
- A patient with valvular pulmonary stenosis with other minor congenital heart disease that l does not require surgical intervention.
Tyshak Catheter (K991977, K003114, K011557) - This catheter is recommended for
Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.
- A patient with isolated pulmonary stenosis u
- A patient with valvular pulmonary stenosis with other minor congenital heart disease that ■ does not require surgical intervention. And;
(K931009, K011557) This catheter is recommended for Percutaneous Transluminal Angioplasty (RSS1007, Norths of I'ms cancenal arteries. These catheters are not designed to be used in the coronary arteries.
{4}------------------------------------------------
Tyshak II Catheter (K003052, K011557, K030589) - This catheter is recommended for I Yshak II Catherer in Catherer (PTV) of the pulmonary valve.
- A patient with isolated pulmonary stenosis i
- A patient with isolated pulmonary stenosis
A patient with valvular pulmonary stenosis with other minor congenital heart disease that I does not require surgical intervention. And;
Z-MED II Catheter (K003052, K011557, K030589) - This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.
- A patient with isolated pulmonary stenosis .
- A patient with isolated pulmonary stenosis with other minor congenital heart disease that l does not require surgical intervention. And;
High Pressure PTA (Marauder) (K010880, K011557) - This catheter is recommended for right Fressure I 17x (maraduct) (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.
Z-5 Atrioseptostomy (K960070, K011557) - Used for the palliation of several congenital heart 2-5 All loseptosition of the great arteries, total anomalous pulmonary venous drainage without delects. transposition of the Ereal arcess, mitral stenosis, mitral atresia, and pulmonary atresia with intact ventricular septum.
Z-5 Braided Atrioseptostomy (K001804, K011557) - Used for the palliation of several 2-3 Draided Attrioseptostom. (2001 of the great arteries, total anomalous pulmonary venous congential licar delected transportion, tricuspid atresia, mitral stenosis, mitral atressa, and pulmonary atresia with intact ventricular septum.
Tyshak X Catheter (K022722) - This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.
- A patient with isolated pulmonary stenosis .
- A patient with valvular pulmonary stenosis with other minor congenital heart disease that I does not require surgical intervention.
Tyshak II X Catheter (K022722) - This catheter is recommended for Percutaneous
Transluminal Valvuloplasty (PTV) of the pulmonary valve.
- A patient with isolated pulmonary stenosis .
- A patient with valvular pulmonary stenosis with other minor congenital heart disease that 1 does not require surgical intervention.
Z-MED X Catheter (K022722) - This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.
- A patient with isolated pulmonary stenosis a
- A patient with valvular pulmonary stenosis with other minor congenital heart disease that . does not require surgical intervention.
pg 2 of 3
{5}------------------------------------------------
Z ·MED II X Catheter (K022722) - This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.
- A patient with isolated pulmonary stenosis .
- A patient with valvular pulmonary stenosis with other minor congenital heart disease that . does not require surgical intervention.
COEfficient Catheter (K014124) - This catheter is recommended for Percutaneous
Transluminal Valvuloplasty (PTV) of the pulmonary valve.
- A patient with isolated pulmonary stenosis ﺎ
- A patient with isolated pulmonary stenosis with other minor congenital heart disease that I does not require surgical intervention.
Ghost PTA (K931009, K011557) - This catheter is recommended for Percutaneous Gross ITTA (KSJ1007) RW115872 - The femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.
Mullins PTA (K013601) - This catheter is recommended for Percutaneous Transluminal Millins ITA (INVL001) - This Satileter and renal arteries. These catheters are not designed to be used in the coronary arteries.
Mullins X PTA (K022722)_- This catheter is recommended for Percutaneous Transluminal Mullins A F FA (XN22122) - Frid Sains and renal arteries. These catheters are not designed to be used in the coronary arteries.
PTS (K003320, K011557) - For use in those patients with cardiovascular defects wherein accurate measurement of the defect is important to select the appropriately sized occluder device.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Donna R. Jochner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K040830
Page 3 of 3
DRL
618104
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