510(k) K962154

Device: CARBOMEDICS HANDLE
Applicant: CARBOMEDICS, INC.
510(k) number: K962154
Product code: DTJ
Decision: Substantially Equivalent (SESE)
Decision date: 1996-08-27
Date received: 1996-06-04
Regulation: 870.3935
Classification name: Holder, Heart-valve, Prosthesis
Medical specialty: Cardiovascular
Review panel: Cardiovascular
Device class: 1
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: JOY FISHER-SHUGART
Address: 1300 E. Anderson Ln. Austin TX US 78752 78752

FDA Registration Numbers#

1721676
3007113487
3005687633
1063481
2025587
2015691
3010701807
3008500478
1649833
2133928
2134285
3008592544
2135147

Source Documents#

Other 510(k) Records For Product Code DTJ #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K960169	CARBOMEDICS VALVE TESTER	Carbomedics, Inc.	1996-04-15
K944214	BAXTER HANDLE MODEL 1150	Baxter Edwards	1995-02-10
K942736	CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLE	Carbomedics, Inc.	1994-07-06
K880052	EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR	Baxter Healthcare Corp	1988-04-01
K871596	IONESCU-SHILEY PERICARDIAL XENOGRAFT (ISU)	Shiley, Inc.	1987-06-15
K864155	MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS	American Edwards Laboratories	1986-11-20
K813276	IONESCU-SHILEY VALVE HOLDER & HANDLE	Shiley, Inc.	1981-12-10
K811235	DISPOSABLE HOLDER FOR HANCOCK MITRAL	Vascor, Inc.	1981-05-13
K811236	DISPOSABLE HOLDER FOR HANCOCK AORTIC	Vascor, Inc.	1981-05-13
K792034	INTEGRAL DISPOSABLE HOLDER CARPENTIER	Edwards Laboratories	1979-12-07
K790022	DISPOSABLE HOLDER FOR BIOPROSTHESIS	Edwards Laboratories	1979-01-15

Legacy Summary#

summary

FDA Review#

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