FDA 510(k) Applications Submitted by TIMOTHY J. TALCOTT
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K960429 |
01/31/1996 |
PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA |
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. |
| K980466 |
02/06/1998 |
PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA |
SIMS PORTEX, INC. |
| K981035 |
03/19/1998 |
PRO-VENT, PULSATOR ARTERIAL BLOOD SAMPLING SYRINGES |
SIMS PORTEX, INC. |
| K031057 |
04/03/2003 |
PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT |
PORTEX, INC. |
| K151386 |
05/26/2015 |
C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic |
ATRIUM MEDICAL CORPORATION |
| K991861 |
06/01/1999 |
1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST RE |
SIMS PORTEX, INC. |
| K061513 |
06/01/2006 |
LEVEL 1 SNUGGLE WARM PEDIATRIC AND LARGE PEDIATRIC UNDERBODY BLANKET |
SMITHS MEDICAL ASD, INC. |
| K962175 |
06/05/1996 |
PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE |
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. |
| K992057 |
06/18/1999 |
IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006 |
SIMS PORTEX, INC. |
| K972385 |
06/26/1997 |
FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED |
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. |
| K002201 |
07/20/2000 |
ELECTROSTATIC HYDROPHOBIC BREATHING FILTER |
SIMS PORTEX, INC. |
| K992471 |
07/26/1999 |
SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17; 21G MODEL# 4910-18 |
SIMS PORTEX, INC. |
| K962931 |
07/29/1996 |
SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT |
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. |
| K002506 |
08/15/2000 |
BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT |
SIMS PORTEX, INC. |
| K963570 |
09/05/1996 |
SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22) |
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. |
| K993619 |
10/26/1999 |
CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK |
SIMS PORTEX, INC. |
| K983858 |
11/02/1998 |
SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES |
SIMS PORTEX, INC. |
| K014115 |
12/14/2001 |
1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX |
PORTEX, INC. |
| K965017 |
12/16/1996 |
REGIONAL ANESTHESIA TRAYS |
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. |
| K994275 |
12/20/1999 |
SIMS PORTEX ANESTHESIA CATHETER |
SIMS PORTEX, INC. |
| K151437 |
05/29/2015 |
ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug |
ATRIUM MEDICAL CORPORATION |
|
|
