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FDA 510(k)

TETRAD TC-C3-ACP

K-Number: K002193 · 2001-05-04

ApplicantTetrad Corp.
Decision Date2001-05-04
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TETRAD TC-C3-ACP is the device name listed in this FDA 510(k) record. The listed applicant is Tetrad Corp.. It received FDA 510(k) clearance on 2001-05-04 under 510(k) number K002193. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TETRAD TC-C3-ACP?

TETRAD TC-C3-ACP is a medical device that received FDA 510(k) clearance on 2001-05-04. The listed applicant is Tetrad Corp.. The 510(k) number is K002193.

When did TETRAD TC-C3-ACP receive FDA 510(k) clearance?

TETRAD TC-C3-ACP received FDA 510(k) clearance on 2001-05-04, under 510(k) number K002193.

Who is the listed applicant for TETRAD TC-C3-ACP?

The FDA 510(k) record lists Tetrad Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TETRAD TC-C3-ACP?

The FDA product code for TETRAD TC-C3-ACP is ITX.

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Other records listing Tetrad Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K042620SONATA 3-D IMAGING ACCESSORY, MODEL 3DSK014182TETRAD MODEL TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP TRANSDUCERSK013849TETRAD MODEL TC-EC7-ACP, -L5-, -L7-, -V4-ACP TRANSDUCERS

Related Devices (Code: ITX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, Inc.

Official Source

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