MANAN

{0}------------------------------------------------ Image /page/0/Picture/8 description: The image shows the logo for MDTECH MEDICAL DEVICE TECHNOLOGIES INC. The logo is in black and white and features the letters "MDTECH" in a bold, sans-serif font. Below the letters is the text "MEDICAL DEVICE TECHNOLOGIES INC." in a smaller font. The logo is simple and modern. - - 4445-310 S.W. 35th Terrace Gainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662 ## 14974743 APR - 6 1998 ## 510(k) SUMMARY | APPLICANT: | Medical Device Technologies, Inc.<br>4445-310 SW 35th Terrace<br>Gainesville, FL 32608 | | |--------------------------|----------------------------------------------------------------------------------------|------------| | CONTACT: | Karl Swartz<br>Quality Assurance Manager | | | TELEPHONE: | (352)338-0440<br>fax (352)338-0662 | | | TRADE NAMES: | Manan™ Seldinger Needle | | | COMMON NAME: | Seldinger needle | | | CLASSIFICATION NAME: | Angiographic Needle - 74HAQ | | | SUBSTANTIAL EQUIVALENCE: | | | | Company Name | Product Name | 510(k) No. | | Manan Medical Products | Seldinger needle | K851833 | | DESCRIPTION OF DEVICE: | | | This needle is made in various gauges from 15 to 22 ga, and in various lengths from 2 to 3 ins. It is a two piece assembly made up of an outer cannula with a truncated pencil tip which is matched to the inner solid stylet. The inner stylet has a modified chisel bevel which extends past the outer cannula. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR - 6 1998 Mr. Karl Swartz Quality Assurance Manager Medical Device Technologies, Inc. 4445-310 SW 35th Terrace Gainsville, FL 32608 Re : K974742, K974743 and K974745 Manan™ Potts-Cournand Needle, Trade Name: Manan™ Seldinger Needle and Manan™ GWI Guide Wire Introducer Regulatory Class: İI Product Code: DRC Dated: March 18, 1998 Received: March 19, 1998 Dear Mr. Swartz: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Specialm = = = Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In {2}------------------------------------------------ Page 2 - Mr. Karl Swartz addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html". Sincerely yours, Thomas J. Callahan Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and .... ..... Radiological Health Enclosure {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for MDTECH Medical Device Technologies INC. The logo is black and white and features the letters "MDTECH" in a bold, sans-serif font. Below the letters is the text "MEDICAL DEVICE TECHNOLOGIES INC" in a smaller font. The logo is enclosed in a rounded rectangle. -310 S W. 35th 7 inesville. Florida 32 TEL: 352/338-0440 FAX: 352/338-0662 Page_1_of_1_ 510(k) Number (if known): Device Name: Manan™ Seldinger Needle Indications for Use: The Manan™ Seldinger Needle is intended for use for atraumatic percutaneous arterial pressure monitoring. `LEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Thtth Olvision Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K974743 510(k) Number_ Prescription Use_ L (Per 21 CFR 801.109) OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96)