Panels › Cardiovascular › Product code DRC · Class 2
Trocar
Regulation 870.1390
0510(k)s in 12 months (51 all time)
0recalls in 12 months (11 all time)
5recalls that name a 510(k)
Top companies in DRC
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 26, 2024 | K240246 | Accusafe Transseptal Guidewire (GTR31180, GTR31230) Synaptic Medical Corporation | DRC |
| May 17, 2024 | K241042 | SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) Pressure Products Medical Device Manufacturing, LLC | DRC |
| Sep 14, 2022 | K221707 | SafeSept® Transseptal Guidewire (SS-140) Pressure Products Medical Device Manufacturing, LLC | DRC |
| Mar 23, 2022 | K212625 | PathBuilder Transseptal Needle Shanghai Microport EP Medtech Co., Ltd., CN | DRC |
| Mar 5, 2021 | K210328 | SafeSept Blunt Needle Pressure Products Medical Device Manufacturing, LLC | DRC |
| Feb 21, 2018 | K172950 | TSN Transseptal Needle Pressure Products Medical Device Manufacturing, LLC | DRC |
| Feb 16, 2018 | K172934 | Needle Free Transseptal Cannula Pressure Products Medical Device Manufacturing, LLC | DRC |
| Dec 21, 2017 | K172893 | SafeSept Needle Free Transseptal Guidewire Pressure Products Medical Device Manufacturing, LLC | DRC |
| Oct 20, 2017 | K170671 | SafeSept Transseptal Guidewire Pressure Products Medical Device Manufacturing, LLC | DRC |
| Aug 29, 2014 | K132943 | INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE Synaptic Medical Limited, CN | DRC |
| Jan 8, 2014 | K130843 | SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE Oscor, Inc. | DRC |
| Feb 7, 2013 | K122587 | BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208 St Jude Medical | DRC |
| Dec 19, 2012 | K122832 | MOBICATH TRANSSEPTAL NEEDLE Great Batch Medical | DRC |
| Oct 3, 2011 | K111644 | MOBICATH TRANSSEPTAL NEEDLE Great Batch Medical | DRC |
| Nov 14, 2008 | K081986 | SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE Oscor, Inc. | DRC |
| Sep 13, 2007 | K072278 | BRK TRANSSEPTAL NEEDLE St Jude Medical | DRC |
| Oct 13, 2006 | K061070 | HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR Hansen Medical, Inc. | DRC |
| Oct 11, 2002 | K022117 | MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5 Merit Medical Systems, Inc. | DRC |
| Oct 4, 2002 | K022257 | VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006 XXX-9011 XXX Vomed Volzer Medizintechnik GmbH & Co., NL | DRC |
| May 2, 2002 | K011727 | TRANSSEPTAL NEEDLE/TROCAR Thomas Medical Products, Inc. | DRC |
| Oct 12, 2001 | K011373 | INSTRUMENT DAMPING PORT Medcanica, Inc. | DRC |
| Oct 5, 2001 | K011349 | INTERCOSTAL LOCKABLE-DIRECTABLE PORT Medcanica, Inc. | DRC |
| Apr 6, 1998 | K974745 | MANAN GWI GUIDE WIRE INTRODUCER Medical Device Technologies, Inc. | DRC |
| Apr 6, 1998 | K974743 | MANAN Medical Device Technologies, Inc. | DRC |
| Apr 6, 1998 | K974742 | MANAN POTTS-COURNAND NEEDLE Medical Device Technologies, Inc. | DRC |
| May 9, 1997 | K964302 | HEARTPORT THORACIC TROCAR Heartport, Inc. | DRC |
| Mar 12, 1997 | K965051 | HEARTPORT NEEDLE TROCAR Heartport, Inc. | DRC |
| Mar 27, 1996 | K951448 | GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED SINGLE WALL INTRODUCER NEEDLE Global Medical Products, Ltd., VG | DRC |
| May 19, 1994 | K936247 | MEDICON INSTRUMENTS TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES Medicon Instruments, Inc. | DRC |
| May 12, 1994 | K940036 | ENDOSURG DISPOSABLE SECONDARY TROCAR Endosurg | DRC |
| Mar 18, 1993 | K924338 | ARROW-FISCHELL EXTENDED VASCULAR ACCESS NEEDLE Arrow Intl., Inc. | DRC |
| Jun 5, 1992 | K913267 | R-GROUP INTL. ONE WALL PUNCTURE NEEDLE R-Group Intl. | DRC |
| Dec 20, 1991 | K914985 | DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION E-Z-Em, Inc. | DRC |
| Jul 2, 1991 | K911483 | LAPAROSCOPIC TROCAR United States Endoscopy Group, Inc. | DRC |
| Apr 22, 1991 | K911462 | SURGICAL TROCAR Applied Medical | DRC |
| Jul 18, 1990 | K900664 | DISPOSABLE COURNAND, SELDINGER & ONE-WALL NEEDLES Sterimed, Inc. | DRC |
| Nov 14, 1989 | K895455 | SELDINGER PERCUTANEOUS 2 PC NEEDLES Advance Medical Designs, Inc. | DRC |
| Nov 14, 1989 | K895454 | SELDINGER SINGLE WALL; STYLE I & II (FLASHBACK) Advance Medical Designs, Inc. | DRC |
| Jun 15, 1989 | K893707 | AUTO SUTURE SURGIPORT DEPTH GUIDE AND SKIRT United States Surgical, A Division of Tyco Healthc | DRC |
| May 19, 1989 | K890209 | DISPOSABLE ANGIOGRAPHY NEEDLES E-Z-Em, Inc. | DRC |
| May 7, 1987 | K871377 | NAMIC COURNAND STYLE INTRODUCER NEEDLE North American Instrument Corp. | DRC |
| May 6, 1987 | K871382 | NAMIC ONE PART INTRODUCER NEEDLE North American Instrument Corp. | DRC |
| May 6, 1987 | K871378 | NAMIC SELDINGER INTRODUCER NEEDLE North American Instrument Corp. | DRC |
| Jan 15, 1986 | K854293 | MEDSURG POTT-COURNAND NEEDLE Medsurg Industries, Inc. | DRC |
| Jan 13, 1986 | K854294 | MEDSURG SELDINGER NEEDLE Medsurg Industries, Inc. | DRC |
| Jan 8, 1986 | K853132 | EMERSON TRO/CATH TROCAR CATHETERS J. H. Emerson Co. | DRC |
| Mar 12, 1984 | K840529 | STEIGER TUNNELING INSTRUMENT 285 Evermed, Inc. | DRC |
| Jul 20, 1981 | K811964 | VISITEC NEEDLE RANGE (CARDIOVASCULAR) Visitec Co. | DRC |
| Aug 23, 1978 | K781221 | DILUTION KIT, THERMAL, COLD PAC Instrumentation Laboratory CO | DRC |
| Jan 24, 1978 | K772369 | NEEDLES USED IN ANGIOGRAPHIC PROCED. Argon Medical Corp. | DRC |
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