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FDA 510(k)

SPECTRUM VENTRICULAR CATHETER

K-Number: K011812 · 2001-11-08

ApplicantCook, Inc.
Decision Date2001-11-08
Product CodeNHC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SPECTRUM VENTRICULAR CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Cook, Inc.. It received FDA 510(k) clearance on 2001-11-08 under 510(k) number K011812. The device is classified under product code NHC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRUM VENTRICULAR CATHETER?

SPECTRUM VENTRICULAR CATHETER is a medical device that received FDA 510(k) clearance on 2001-11-08. The listed applicant is Cook, Inc.. The 510(k) number is K011812.

When did SPECTRUM VENTRICULAR CATHETER receive FDA 510(k) clearance?

SPECTRUM VENTRICULAR CATHETER received FDA 510(k) clearance on 2001-11-08, under 510(k) number K011812.

Who is the listed applicant for SPECTRUM VENTRICULAR CATHETER?

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

What is the FDA product code for SPECTRUM VENTRICULAR CATHETER?

The FDA product code for SPECTRUM VENTRICULAR CATHETER is NHC.

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Other records listing Cook, Inc. 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.

K133634SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SETK132020ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETERK131201ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SETK131206COOK CERVICAL RIPENING BALLOONK132334TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SETK122091COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY

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Related Devices (Code: NHC)

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.

K160223VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage CatheterCook IncorporatedK071640VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRMCook, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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